OTC Medication Information: Malin and Goetz SPF 30 Face Moisturizer

MALIN AND GOETZ SPF 30 FACE MOISTURIZER- avobenzone, homosalate, octinoxate, octisalate and oxybenzone cream
Malin + Goetz

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 Ingredient Purpose
avobenzone 3% sunscreen
homosalate 10% sunscreen
octinoxate 7.5% sunscreen
octisalate 5% sunscreen
oxybenzone 5% 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 or irritation develops and lasts

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

Directions

  • Apply generously and evenly 15 minutes before sun exposure to clean face
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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
  • Children under 6 months of age: Ask a doctor. Smooth onto face and neck until thoroughly absorbed

Inactive Ingredients

Water (aqua), c12-15 alkyl ethylhexanoate, dimethicone, glycerin, vp/eicosene copolymer, phenoxyethanol, peg-20 methyl glucose sesquistearate, methyl glucose sesquistearate, cetyl alcohol, potassium cetyl phosphate, acrylates/c10-30 alkyl acrylate cross- polymer, peg-40 stearate, chlorph- enesin, polysorbate 80, cholesterol, ethylhexylglycerin, sodium benzoate, sodium hydroxide, disodium edta, methylisothiazolinone, panthenol, tetrahexyldecyl ascorbate, aloe barbadensis leaf juice powder, allantoin, tocopherol, camellia oleifera leaf extract, epilobium angustifolium flower/leaf/stem extract

Other information

  • protect this product from excessive heat and direct sun

Questions or comments?

Visit www.malinandgoetz.com or call +1-212-244-7771, M-F, 9am-6pm EST

DISTRIBUTED BY:
MALIN+GOETZ INC.,
210 WEST 29TH ST.,
NEW YORK, NEW YORK 10001

PRINCIPAL DISPLAY PANEL — 48 mL Tube Carton

(MALIN+GOETZ)
spf 30 face moisturizer.

BROAD SPECTRUM SPF 30. ALL SKIN TYPES.
APOTHECARY AND LAB—FM-118-48.

BROAD SPECTRUM SPF 30 HELPS PROTECT AGAINST
SUN DAMAGE WHILE GREEN TEA ANTIOXIDANTS PRO-
VIDE PROTECTION AGAINST ENVIRONMENTAL TOXINS
AND FREE RADICALS. GENTLY MOISTURIZES AND BAL-
ANCES ALL SKIN TYPES. NATURAL FRAGRANCE AND
COLOR. DIRECTIONS: APPLY GENEROUSLY AND EVENLY TO
CLEAN FACE 15 MINUTES BEFORE SUN EXPOSURE. USE A
WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6
MONTHS OF AGE: ASK A DOCTOR. SMOOTH ONTO FACE AND
NECK UNTIL THOROUGHLY ABSORBED. WARNINGS: FOR EXT-
ERNAL 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 OR IRRITATION DEVELOPS AND LASTS. KEEP OUT OF
REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR
CONTACT A POISON CONTROL CENTER RIGHT AWAY. FORM-
ULATED AND DISTRIBUTED BY: MALIN+GOETZ INC., 210 WEST
29TH ST., NEW YORK, NEW YORK 10001, TEL +1 212 244 7771.
WWW.MALINANDGOETZ.COM. MALIN+GOETZ DOES NOT TEST ON ANIMALS. MADE IN USA.

1.7fl.oz.℮48ml

PRINCIPAL DISPLAY PANEL -- 48 mL Tube Carton
(click image for full-size original)
MALIN AND GOETZ SPF 30 FACE MOISTURIZER avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53634-254
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
avobenzone (avobenzone) avobenzone 30 mg in 1 mL
homosalate (homosalate) homosalate 100 mg in 1 mL
octinoxate (octinoxate) octinoxate 75 mg in 1 mL
octisalate (octisalate) octisalate 50 mg in 1 mL
oxybenzone (oxybenzone) oxybenzone 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water
c12-15 alkyl ethylhexanoate
dimethicone
glycerin
phenoxyethanol
peg-20 methyl glucose sesquistearate
cetyl alcohol
potassium cetyl phosphate
peg-40 stearate
chlorphenesin
polysorbate 80
cholesterol
ethylhexylglycerin
sodium benzoate
sodium hydroxide
edetate disodium
methylisothiazolinone
panthenol
tetrahexyldecyl ascorbate
aloe vera leaf
allantoin
tocopherol
camellia oleifera leaf
epilobium angustifolium flowering top
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53634-254-50 1 TUBE in 1 CARTON contains a TUBE
1 48 mL in 1 TUBE This package is contained within the CARTON (53634-254-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 01/01/2014
Labeler — Malin + Goetz (138615930)
Registrant — Milbar Laboratories,Inc. (195556790)
Establishment
Name Address ID/FEI Operations
Milbar Laboratories,Inc. 195556790 MANUFACTURE (53634-254)

Revised: 08/2014 Malin + Goetz

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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