Label: CETAPHIL SHEER MINERAL SUNSCREEN STICK SPF 50- titanium dioxide, zinc oxide stick
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- NDC Code(s): 0299-4108-00
- Packager: Galderma Laboratories, L.P.
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated August 2, 2022
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- Active Ingredients...……….....Purpose
- Uses
- Warnings For external use only
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months of age: Ask a doctor
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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 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
▪ protect the product in this container from excessive heat and direct sun
▪ may stain or damage some fabrics
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Inactive Ingredients
ALUMINUM HYDROXIDE, BEESWAX, BHT, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CETYL ALCOHOL, DIMETHICONE, EUPHORBIA CERIFERA (CANDELILLA) WAX, ISOSTEARIC ACID, NEOPENTYL GLYCOL DIETHYLHEXANOATE, OZOKERITE, PARAFFIN, POLYETHYLENE, STEARIC ACID, TOCOPHERYL ACETATE (VITAMIN E), TRIETHOXYCAPRYLYLSILANE
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 0.5 OZ Card
#1 Doctor Recommended
Sensitive Skincare Brand
Cetaphil®
SUN
50
Sheer Mineral Sunscreen Stick
Broad Spectrum SFP 50
Formulated for sensitive skin, Microbiome gentle,
Water resistant (80 minutes)
Vitamin E
NET WT 0.5 OZ (14 g)
National Eczema Association logo
Distributed by:
Galderma Laboratories, L.P.
Fort Worth, TX 76177 USA
All trademarks are the property of their respective owners
cetaphil.com
P55345-1
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INGREDIENTS AND APPEARANCE
CETAPHIL SHEER MINERAL SUNSCREEN STICK SPF 50
titanium dioxide, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-4108 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 47 mg in 1 g Inactive Ingredients Ingredient Name Strength Aluminum Hydroxide (UNII: 5QB0T2IUN0) Yellow Wax (UNII: 2ZA36H0S2V) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Cetyl Alcohol (UNII: 936JST6JCN) Dimethicone (UNII: 92RU3N3Y1O) Candelilla Wax (UNII: WL0328HX19) Isostearic Acid (UNII: X33R8U0062) Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C) Ceresin (UNII: Q1LS2UJO3A) Paraffin (UNII: I9O0E3H2ZE) High Density Polyethylene (UNII: UG00KM4WR7) Stearic Acid (UNII: 4ELV7Z65AP) .Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N) Triethoxycaprylylsilane (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0299-4108-00 1 in 1 BLISTER PACK 11/01/2020 1 14 g in 1 CANISTER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/01/2020 Labeler - Galderma Laboratories, L.P. (047350186) Establishment Name Address ID/FEI Business Operations Fruit of The Earth Research Laboratories, Inc. 008193513 manufacture(0299-4108)