OTC Medication Information: A PERFECT WORLD SPF 35 UV BROAD SPECTRUM FACE PROTECTOR

A PERFECT WORLD SPF 35 UV BROAD SPECTRUM FACE PROTECTOR- homosalate, octisalate, avobenzone and octocrylene lotion
ORIGINS NATURAL RESOURCES INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients Purpose
avobenzone 3.00% Sunscreen
homosalate 5.00% Sunscreen
octisalate 5.00% Sunscreen
octocrylene 2.70% Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10am – 2pm
    • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Inactive ingredients

water\aqua\eau; citrus aurantium amara (bitter orange) flower water, anthemis nobilis (chamomile) flower water • butyloctyl salicylate • methyl trimethicone • jojoba esters • polyester-8 • ethyl macadamiate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • butylene glycol • peg-100 stearate • glyceryl stearate • citrus aurantium bergamia (bergamot) fruit oil 1, citrus medica limonum (lemon) peel oil 1, citrus aurantium dulcis (orange) oil 1, cinnamomum camphora (camphor) bark oil 1, mentha viridis (spearmint) leaf oil 1, magnolia acuminata flower extract, iris pallida (orris) root extract, rosa damascena (rose) extract, citral, linalool, limonene • camellia sinensis (white tea) leaf extract • pinus pinaster bark/bud extract • arabidopsis thaliana extract • ascorbyl tocopheryl maleate • oryzanol • ergothioneine • triticum vulgare (wheat) germ extract • laminaria saccharina extract • mangifera indica (mango) seed butter • butyrospermum parkii (shea butter) • potassium cetyl phosphate • caffeine • cholesterol • linoleic acid • hordeum vulgare (barley) extract\extrait d’orge • cetyl alcohol • ethylhexylglycerin • trioctyldodecyl citrate • lecithin • squalane • dehydroxanthan gum • caprylyl glycol • sodium hyaluronate • ammonium acryloyldimethyltaurate/vp copolymer • silica • sodium stearate • citric acid • sodium dehydroacetate • phenoxyethanol • mica • iron oxides (ci 77491, ci 77492, ci 77499) <iln36397>


1
essential oil

Other information

protect the product in this container from excessive heat and direct sun

Dist.
New York, NY 10022

PRINCIPAL DISPLAY PANEL — 40 ml Tube Carton

ORIGINS

A Perfect World™ SPF 35
UV Face protector
with White Tea

Broad Spectrum SPF 35
1.4 fl. oz./oz. liq./40 ml e

Principal Display Panel -- 40 ml Tube Carton
(click image for full-size original)
A PERFECT WORLD SPF 35 UV BROAD SPECTRUM FACE PROTECTOR
homosalate, octisalate, avobenzone, octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-706
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 5 mL in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 mL in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 mL in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 2.7 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
water
citrus aurantium flower oil
chamaemelum nobile flower oil
butyloctyl salicylate
methyl trimethicone
ethyl macadamiate
butylene glycol
peg-100 stearate
glyceryl monostearate
bergamot oil
lemon oil
orange oil
camphor oil
spearmint oil
magnolia acuminata flower
iris pallida root
rosa damascena flower
citral
linalool, (+/-)-
maritime pine
gamma oryzanol
ergothioneine
wheat germ
saccharina latissima thallus
mangifera indica seed butter
shea butter
potassium cetyl phosphate
caffeine
cholesterol
linoleic acid
cetyl alcohol
ethylhexylglycerin
squalane
caprylyl glycol
hyaluronate sodium
ammonium acryloyldimethyltaurate/vp copolymer
silicon dioxide
sodium stearate
citric acid monohydrate
sodium dehydroacetate
phenoxyethanol
mica
ferric oxide red
ferric oxide yellow
ferrosoferric oxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59427-706-01 1 TUBE (TUBE) in 1 CARTON contains a TUBE (59427-706-02)
1 NDC:59427-706-02 40 mL in 1 TUBE This package is contained within the CARTON (59427-706-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2010
Labeler — ORIGINS NATURAL RESOURCES INC (611716283)
Establishment
Name Address ID/FEI Operations
ELGC K.K. 712808195 RELABEL (59427-706), REPACK (59427-706)
Establishment
Name Address ID/FEI Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE (59427-706), RELABEL (59427-706), REPACK (59427-706)
Establishment
Name Address ID/FEI Operations
Estee Lauder Inc. 042918826 MANUFACTURE (59427-706)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK (59427-706), RELABEL (59427-706)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE (59427-706)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE (59427-706)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE (59427-706)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER N.V. 370151326 MANUFACTURE (59427-706)
Establishment
Name Address ID/FEI Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE (59427-706)
Establishment
Name Address ID/FEI Operations
NORTEC KEYSTONE 943871157 MANUFACTURE (59427-706), RELABEL (59427-706), REPACK (59427-706)
Establishment
Name Address ID/FEI Operations
NORTHTEC BRISTOL 959338336 MANUFACTURE (59427-706), RELABEL (59427-706), REPACK (59427-706)
Establishment
Name Address ID/FEI Operations
NORTHTEC KEYSTONE 949264774 MANUFACTURE (59427-706), RELABEL (59427-706), REPACK (59427-706)
Establishment
Name Address ID/FEI Operations
WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE (59427-706)
Establishment
Name Address ID/FEI Operations
Aveda Corporation 071352058 MANUFACTURE (59427-706)
Establishment
Name Address ID/FEI Operations
Pennsylvania Logistics Center 078364654 REPACK (59427-706), RELABEL (59427-706)

Revised: 04/2012 ORIGINS NATURAL RESOURCES INC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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