OTC Medication Information: Jafra Royal Jelly Radiance Broad Spectrum SPF 20 Bare L6

JAFRA ROYAL JELLY RADIANCE BROAD SPECTRUM SPF 20 BARE L6- octinoxate and zinc oxide emulsion
Absara Cosmetics S.A.P.I DE C.V.

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

Octinoxate 3%

Zinc Oxide 6.8%

Purpose

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

Stop use and ask a doctor

if rash occurs

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before use exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor
  • 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 of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. -2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

Water/Aqua, Titanium Dioxide, Triethoxycaprylylsilane, Caprylic, Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Dimethicone, C12-15 Alkyl Benzoate, Phenyl Dimethicone, Phenyl Trimethicone, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Squalane, Di-PPG-3 Myristyl Ether Adipate Caprylyl Methicone, Dimethicone, PEG-10 Dimethicone, Dissteardimonium Hectorite, Boron Nitride, Royal Jelly, Propanediol, Sodium Chloride, DMDM Hyantoin, Dextrin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Panthenol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Withania Somniferia (Winter Cherry) Extract, Biosaccharide Gum-4, Chlndrus Crispus (Carrageenan) Extract, Smithsonite Extract, Iron Oxides/ CI 77491/CI 77492/CI 77499

Other information

protect this product from excessive heat and direct sun

Package Labeling:

Royal Jelly Label
(click image for full-size original)

JAFRA ROYAL JELLY RADIANCE BROAD SPECTRUM SPF 20 BARE L6
octinoxate, zinc oxide emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70956-305
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 30 mg in 1 mL
ZINC OXIDE (ZINC CATION) ZINC CATION 68 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TITANIUM DIOXIDE
TRIETHOXYCAPRYLYLSILANE
MEDIUM-CHAIN TRIGLYCERIDES
CYCLOMETHICONE
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE
ALKYL (C12-15) BENZOATE
PHENYL TRIMETHICONE
CYCLOMETHICONE 5
SQUALANE
DI-PPG-3 MYRISTYL ETHER ADIPATE
CAPRYLYL TRISILOXANE
DIMETHICONE
PEG-10 DIMETHICONE (600 CST)
DISTEARDIMONIUM HECTORITE
BORON NITRIDE
ROYAL JELLY
PROPANEDIOL
SODIUM CHLORIDE
DMDM HYDANTOIN
DEXTRIN PALMITATE (CORN; 20000 MW)
RICE BRAN
ROSEMARY
HELIANTHUS ANNUUS FLOWERING TOP
TOCOPHEROL
PANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
PEG-4 LAURATE
IODOPROPYNYL BUTYLCARBAMATE
CINIDON-ETHYL
BIOSACCHARIDE GUM-4
CHONDRUS CRISPUS CARRAGEENAN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70956-305-00 1 BOTTLE in 1 BOX contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the BOX (70956-305-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 11/29/2016
Labeler — Absara Cosmetics S.A.P.I DE C.V. (816161236)
Establishment
Name Address ID/FEI Operations
Absara Cosmetics S.A.P.I DE C.V. 816161236 manufacture (70956-305)

Revised: 01/2021 Absara Cosmetics S.A.P.I DE C.V.

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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