Label: CETAPHIL SHEER MINERAL SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 0299-4122-00
- Packager: Galderma Laboratories, L.P.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 20, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- OTC - PURPOSE SECTION
- 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.
-
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
-
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
WATER, ISOHEXADECANE, BUTYLOCTYL SALICYLATE, CETYL DIMETHICONE, STYRENE/ACRYLATES COPOLYMER, OLIVE OIL POLYGLYCERYL-6 ESTERS, SORBITAN OLIVATE, SODIUM STEAROYL LACTYLATE, VP/EICOSENE COPOLYMER, CETEARYL ALCOHOL, CETEARYL OLIVATE, CETYL PALMITATE, SORBITAN PALMITATE, DIMETHICONE PEG-8 LAURATE, CERAMIDE NP, CERAMIDE AP, CERAMIDE EOP, CHOLESTEROL, PHYTOSPHINGOSINE, HYDROLYZED HYALURONIC ACID, BENZYL ALCOHOL, BISABOLOL, DIPOTASSIUM GLYCYRRHIZATE, PROPANEDIOL, XANTHAN GUM, ALUMINUM HYDROXIDE, SODIUM LAUROYL LACTYLATE, CARBOMER, TOCOPHERYL ACETATE, DISODIUM EDTA, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, CITRIC ACID, MALTODEXTRIN, PHENOXYETHANOL, CAPRYLOYL GLYCINE, UNDECYLENOYL GLYCINE
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - 3 FL OZ TUBE
#1 Doctor Recommended
Sensitive Skincare Brand
Cetaphil®
SUN
50
Sheer Mineral Sunscreen
Broad Spectrum SPF 50
Formulated for sensitive skin
Microbiome gentle formula
nourishes sensitive skin while
providing hydrating,
chemical-free sun protection
Water resistant (80 minutes)
Prebiotics & Vitamin E
National Eczema Association logo
3 FL OZ (89 mL)
Distributed by:
Galderma Laboratories, L.P.
Fort Worth, TX 76177 USA
All trademarks are the property of their respective owners.
cetaphil.com
P55348-1
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INGREDIENTS AND APPEARANCE
CETAPHIL SHEER MINERAL SUNSCREEN SPF 50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-4122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 90 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Isohexadecane (UNII: 918X1OUF1E) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Cetyl Dimethicone 150 (UNII: 5L694Y0T22) Styrene/Acrylamide Copolymer (500000 Mw) (UNII: 5Z4DPO246A) Olive Oil Polyglyceryl-6 Esters (UNII: 4KDO9AFM9I) Sorbitan Olivate (UNII: MDL271E3GR) Sodium Stearoyl Lactylate (UNII: IN99IT31LN) Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cetearyl Olivate (UNII: 58B69Q84JO) Cetyl Palmitate (UNII: 5ZA2S6B08X) Sorbitan Monopalmitate (UNII: 77K6Z421KU) Dimethicone Peg-8 Laurate (UNII: 72MF9C2A18) Ceramide Np (UNII: 4370DF050B) Ceramide Ap (UNII: F1X8L2B00J) Ceramide 1 (UNII: 5THT33P7X7) Cholesterol (UNII: 97C5T2UQ7J) Phytosphingosine (UNII: GIN46U9Q2Q) Benzyl Alcohol (UNII: LKG8494WBH) Levomenol (UNII: 24WE03BX2T) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Propanediol (UNII: 5965N8W85T) Xanthan Gum (UNII: TTV12P4NEE) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Sodium Lauroyl Lactylate (UNII: 7243K85WFO) Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Edetate Disodium (UNII: 7FLD91C86K) Stearic Acid (UNII: 4ELV7Z65AP) Triethoxycaprylylsilane (UNII: LDC331P08E) Citric Acid Monohydrate (UNII: 2968PHW8QP) Maltodextrin (UNII: 7CVR7L4A2D) Phenoxyethanol (UNII: HIE492ZZ3T) Capryloyl Glycine (UNII: 8TY5YO42NJ) Undecylenoyl Glycine (UNII: 4D20464K2J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0299-4122-00 89 mL in 1 TUBE; Type 0: Not a Combination Product 10/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2021 Labeler - Galderma Laboratories, L.P. (047350186) Establishment Name Address ID/FEI Business Operations Fruit of The Earth Research Laboratories, Inc. 008193513 manufacture(0299-4122) Establishment Name Address ID/FEI Business Operations Fruit of The Earth, Inc. 080086802 manufacture(0299-4122)