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

Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., ENGLEWOOD LAB, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients.....Purpose

Homosalate 9.5% .................Sunscreen
Octocrylene 9.5% .........… Sunscreen
Octisalate 4.8% ...............…   Sunscreen
Avobenzone 2.8% ................. Sunscreen

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, GLYCERIN, DIPROPYLENE GLYCOL, PANTHENOL, BUTYLOCTYL SALICYLATE, SILICA, BEESWAX, NIACINAMIDE, CETEARYL OLIVATE, SODIUM STEAROYL LACTYLATE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PALMITIC ACID, ETHYLHEXYLGLYCERIN, LEONTOPODIUM ALPINUM EXTRACT, STEARIC ACID, 1,2-HEXANEDIOL, ORYZA SATIVA (RICE) LEES EXTRACT, SODIUM HYDROXIDE, PROPANEDIOL, ADENOSINE, CITRIC ACID, HYDROLYZED SOY FLOUR, BUDDLEJA DAVIDII EXTRACT, THYMUS VULGARIS (THYME) EXTRACT

Questions or comments?

1-866-735-4137

Principal Display Panel - 1.7 OZ Carton

RETINOL ALTERNATIVE

Dermatologist Recommended
For Sensitive Skin

Cetaphil®

HEALTHY RENEW

Day Cream
Broad Spectrum
SPF 30
Purified Peptides
Hydrates to visibly smooth the
look of fine lines and protects
from damaging UV rays

Five Skin Sensitivity Signs

NET WT 1.7 OZ (48 g)

Distributed by:
Galderma Laboratories, L.P., Dallas, TX 75201 USA
All trademarks are the property of their respective owners.
cetaphil.com  
P57224-1

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4136
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	95 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	95 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	48 mg  in 1 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	28 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Dipropylene Glycol (UNII: E107L85C40)
Panthenol (UNII: WV9CM0O67Z)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Yellow Wax (UNII: 2ZA36H0S2V)
Niacinamide (UNII: 25X51I8RD4)
Cetearyl Olivate (UNII: 58B69Q84JO)
Sodium Stearoyl Lactylate (UNII: IN99IT31LN)
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)
Leontopodium Nivale Subsp. Alpinum Root (UNII: SDW6SS1K6I)
Stearic Acid (UNII: 4ELV7Z65AP)
1,2-Hexanediol (UNII: TR046Y3K1G)
Rice Germ (UNII: 7N2B70SFEZ)
Sodium Hydroxide (UNII: 55X04QC32I)
Propanediol (UNII: 5965N8W85T)
Adenosine (UNII: K72T3FS567)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Hydrolyzed Soy Protein (Enzymatic; 2000 Mw) (UNII: 1394NXB9L6)
Buddleja Davidii Whole (UNII: 8JZ8B2V1OV)
Thyme (UNII: CW657OBU4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4136-00	1 in 1 CARTON	04/12/2023
1		48 g in 1 TUBE; 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	04/12/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
ENGLEWOOD LAB, INC.		172198223	manufacture(0299-4136)