Label: CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 35- avobenzone, homosalate, octisalate, octocrylene lotion
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- NDC Code(s): 0299-4113-05
- 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 March 2, 2021
If you are a consumer or patient please visit this version.
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- Active Ingredients.....Purpose
- Uses
- Warnings
- 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
- use a water resistant sunscreen if swimming or sweating
- reapply 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
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Inactive Ingredients
Water, Glycerin, Dipropylene Glycol, Panthenol (Vitamin B5), Ethylhexyl Methoxycrylene, lsopropyl Palmitate, Silica, Niacinamide, Cetearyl 0livate, Cetearyl Alcohol, Glyceryl Stearate, Potassium Cetyl Phosphate, Sorbitan 0livate, Tocopheryl Acetate (Vitamin E Acetate), Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Palmitic Acid, Ethylhexylglycerin, Stearic Acid, Leontopodium Alpinum Flower/Leaf Extract, 1,2-Hexanediol, 0ryza Saliva (Rice) Lees Extract, Propanediol, Sodium Hydroxide, Adenosine, Citric Acid, Myristic Acid, Tocopherol (Vitamin E), Buddleja Davidii (Summer Lilac) Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract
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Principal Display Panel - 3 FL OZ Carton
DERMATOLOGIST RECOMMENDED
FOR SENSITIVE SKIN
Cetaphil®
Daily Oil - FreeFacial Moisturizer
with sunscreen
BROAD SPECTRUM SPF 35
35Combination, sensitive skin
Lightweight lotion
hydrates and protects skin
from sun damage
Antioxidants & ProVitamin B5
Skin Cancer Foundation logo
3 FL OZ (88mL)
Distributed by:
Galderma Laboratories, L.P.
Dallas, Texas 75201 USA
All trademarks are the property of their respective owners.
cetaphil.com
P56561-1
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INGREDIENTS AND APPEARANCE
CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 35
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-4113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 28 mg in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 95 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 48 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Dipropylene Glycol (UNII: E107L85C40) Panthenol (UNII: WV9CM0O67Z) Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8) Isopropyl Palmitate (UNII: 8CRQ2TH63M) Silicon Dioxide (UNII: ETJ7Z6XBU4) Niacinamide (UNII: 25X51I8RD4) Cetearyl Olivate (UNII: 58B69Q84JO) Cetostearyl Alcohol (UNII: 2DMT128M1S) Glyceryl Monostearate (UNII: 230OU9XXE4) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Sorbitan Olivate (UNII: MDL271E3GR) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Caprylyl Glycol (UNII: 00YIU5438U) Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO) Palmitic Acid (UNII: 2V16EO95H1) Ethylhexylglycerin (UNII: 147D247K3P) Stearic Acid (UNII: 4ELV7Z65AP) Leontopodium Nivale Subsp. Alpinum Flowering Top (UNII: QQC1AK06RK) 1,2-Hexanediol (UNII: TR046Y3K1G) Rice Germ (UNII: 7N2B70SFEZ) Propanediol (UNII: 5965N8W85T) Sodium Hydroxide (UNII: 55X04QC32I) Adenosine (UNII: K72T3FS567) Citric Acid Monohydrate (UNII: 2968PHW8QP) Myristic Acid (UNII: 0I3V7S25AW) Tocopherol (UNII: R0ZB2556P8) Buddleja Davidii Leaf (UNII: X380815D32) Thymus Vulgaris Leaf (UNII: GRX3499643) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0299-4113-05 1 in 1 CARTON 11/01/2020 1 88 mL in 1 BOTTLE, PUMP; 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 ENGLEWOOD LAB, INC. 172198223 label(0299-4113) , manufacture(0299-4113) , pack(0299-4113)