Label: CETAPHIL SHEER MINERAL SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion
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- NDC Code(s): 0299-4112-00, 0299-4112-05
- Packager: Galderma Laboratories, L.P.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 February 7, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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.
-
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
alumina, arachidyl alcohol, arachidyl glucoside, ascorbic acid, avena sativa (oat) kernel extract, beeswax, behenyl alcohol, benzyl alcohol, bisabolol, butylene glycol, butyloctyl salicylate, calendula officinalis flower extract, camellia sinensis leaf extract, carbomer, ceramide AP, ceramide EOP, ceramide NP, cetyl dimethicone, chamomilla recutita (matricaria) flower extract, cholesterol, dimethicone, dimethicone PEG-8 laurate, dipotassium glycyrrhizate, disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate, hydrated silica, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, methicone, panthenol, pantothenic acid, PEG-100 stearate, PEG-8, phytosphingosine, polyaminopropyl biguanide, polymethyl methacrylate, polysorbate 60, potassium sorbate, propylene glycol, sodium lauroyl lactylate, stearic acid, styrene/acrylates copolymer, tocopheryl acetate(vitamin E), triethoxycaprylylsilane, trimethylsiloxysilicate, trisiloxane, VP/eicosene copolymer, water, xanthan gum.
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PRINCIPAL DISPLAY PANEL - 3 FL OZ TUBE
NEW & IMPROVED
Dermatologist Recommended
#1 Facial 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 and 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
P55348-0
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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:0299-4112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 49 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 47 mg in 1 mL Inactive Ingredients Ingredient Name Strength Aluminum Hydroxide (UNII: 5QB0T2IUN0) Arachidyl Alcohol (UNII: 1QR1QRA9BU) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Ascorbic Acid (UNII: PQ6CK8PD0R) Oat (UNII: Z6J799EAJK) Yellow Wax (UNII: 2ZA36H0S2V) Docosanol (UNII: 9G1OE216XY) Benzyl Alcohol (UNII: LKG8494WBH) Levomenol (UNII: 24WE03BX2T) Butylene Glycol (UNII: 3XUS85K0RA) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Calendula Officinalis Flower (UNII: P0M7O4Y7YD) Green Tea Leaf (UNII: W2ZU1RY8B0) Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC) Ceramide Ap (UNII: F1X8L2B00J) Ceramide 1 (UNII: 5THT33P7X7) Ceramide Np (UNII: 4370DF050B) Cetyl Dimethicone 150 (UNII: 5L694Y0T22) Chamomile (UNII: FGL3685T2X) Cholesterol (UNII: 97C5T2UQ7J) Dimethicone (UNII: 92RU3N3Y1O) Dimethicone Peg-8 Laurate (UNII: 72MF9C2A18) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Edetate Disodium (UNII: 7FLD91C86K) Ethylhexylglycerin (UNII: 147D247K3P) Glycerin (UNII: PDC6A3C0OX) Glyceryl Monostearate (UNII: 230OU9XXE4) Hydrated Silica (UNII: Y6O7T4G8P9) Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.S At 1.5%) (UNII: 86FQE96TZ4) Isohexadecane (UNII: 918X1OUF1E) Maltodextrin (UNII: 7CVR7L4A2D) Methicone (20 Cst) (UNII: 6777U11MKT) Panthenol (UNII: WV9CM0O67Z) Pantothenic Acid (UNII: 19F5HK2737) Peg-100 Stearate (UNII: YD01N1999R) Polyethylene Glycol 400 (UNII: B697894SGQ) Phytosphingosine (UNII: GIN46U9Q2Q) Polihexanide (UNII: 322U039GMF) Poly(Methyl Methacrylate; 450000 Mw) (UNII: Z47NNT4J11) Polysorbate 60 (UNII: CAL22UVI4M) Potassium Sorbate (UNII: 1VPU26JZZ4) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Lauroyl Lactylate (UNII: 7243K85WFO) Stearic Acid (UNII: 4ELV7Z65AP) Styrene/Acrylamide Copolymer (500000 Mw) (UNII: 5Z4DPO246A) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Triethoxycaprylylsilane (UNII: LDC331P08E) Trimethylsiloxysilicate (M/Q 0.6-0.8) (UNII: 5041RX63GN) Trisiloxane (UNII: 9G1ZW13R0G) Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3) Water (UNII: 059QF0KO0R) Xanthan Gum (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0299-4112-00 89 mL in 1 TUBE; Type 0: Not a Combination Product 11/01/2020 2 NDC:0299-4112-05 10 mL in 1 TUBE; Type 0: Not a Combination Product 11/01/2020 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(0299-4112) Establishment Name Address ID/FEI Business Operations Fruit of The Earth, Inc. 080086802 manufacture(0299-4112)