CETAPHIL HEALTHY RADIANCE WHIPPED DAY CREAM BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

Cetaphil Healthy Radiance Whipped Day Cream Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Cetaphil Healthy Radiance Whipped Day Cream Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., Cosmetic Essence, LLC dba Voyant Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients.....Purpose

Avobenzone 3% .................Sunscreen
Homosalate 12.5% .........… Sunscreen
Octisalate 5% ...............…   Sunscreen
Octocrylene 8% ................. Sunscreen

OTC - PURPOSE SECTION

Purpose

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 occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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
• 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

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Butylene Glycol, Isododecane, Sorbitol, Silica, Styrene/Acrylates Copolymer, Cetearyl Alcohol, Niacinamide, Glycerin, Phenoxyethanol, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Phenylethyl Resorcinol, Carbomer, Fatty Acid Ethoxylate, Sorbitan Stearate, Synthetic Fluorphlogopite, Ethylhexylglycerin, Titanium Dioxide, Disodium EDTA, Sodium Hydroxide, Tin Oxide

Questions or comments?

1-866-735-4137

Principal Display Panel - 3 FL OZ Carton

#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®

HEALTHY RADIANCE

Whipped Day Cream
Broad Spectrum SPF 30
Helps even skin tone while protecting,
hydrating and firming skin
GentleBright Complex with Niacinamide

Five Skin Sensitivity Signs

NET WT 1.7 OZ (48 g)

Distributed by:
Galderma Laboratories, L.P., Fort Worth, TX 76177 USA
All trademarks are the property of their respective owners.
Cetaphil.com  
P54853-1

INGREDIENTS AND APPEARANCE

CETAPHIL HEALTHY RADIANCE WHIPPED DAY CREAM BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	125 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Butylene Glycol (UNII: 3XUS85K0RA)
Isododecane (UNII: A8289P68Y2)
Sorbitol (UNII: 506T60A25R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Styrene/Acrylamide Copolymer (500000 Mw) (UNII: 5Z4DPO246A)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Niacinamide (UNII: 25X51I8RD4)
Glycerin (UNII: PDC6A3C0OX)
Phenoxyethanol (UNII: HIE492ZZ3T)
Dimethicone (UNII: 92RU3N3Y1O)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Phenylethyl Resorcinol (UNII: G37UFG162O)
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Magnesium Potassium Aluminosilicate Fluoride (UNII: YK3DC63Y5M)
Ethylhexylglycerin (UNII: 147D247K3P)
Titanium Dioxide (UNII: 15FIX9V2JP)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Sodium Hydroxide (UNII: 55X04QC32I)
Stannic Oxide (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4118-00	1 in 1 CARTON	05/01/2021
1		48 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2021

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC dba Voyant Beauty		032565959	manufacture(0299-4118)