LOREAL PARIS AGE PERFECT CELL RENEWAL DAY MOISTURIZER BROAD SPECTRUM SPF 25 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene cream

LOreal Paris Age Perfect Cell Renewal Day Moisturizer Broad Spectrum SPF 25 Sunscreen by

Drug Labeling and Warnings

LOreal Paris Age Perfect Cell Renewal Day Moisturizer Broad Spectrum SPF 25 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

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

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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

● children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, glycerin, alcohol denat., hydrogenated polyisobutene, bis-PEG-18 methyl ether dimethyl silane, dimethicone, cetearyl alcohol, PEG-100 stearate, PEG-20, petrolatum, butyrospermum parkii (shea) butter, C13-14 isoparaffin, glyceryl stearate, dimethiconol, dimethyl isosorbide, cetearyl glucoside, neohesperidin dihydrochalcone, sodium cocoyl glutamate, sodium hyaluronate, sodium hydroxide, cyclodextrin, adenosine, vigna aconitifolia seed extract, mannitol, disodium EDTA, disodium succinate, hydrolyzed cicer seed extract, capryloyl salicylic acid, laureth-7, yeast extract, xanthan gum, polyacrylamide, acrylates/C10-30 alkyl acrylate crosspolymer, cetyl alcohol, octyldodecanol, tocopheryl acetate, sodium dehydroacetate, phenoxyethanol, red 4, yellow 5, linalool, geraniol, alpha-isomethyl ionone, limonene, hydroxycitronellal, cironellol, hexyl cinnamal, benzyl alcohol, benzyl salicylate, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS AGE PERFECT CELL RENEWAL DAY MOISTURIZER BROAD SPECTRUM SPF 25 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-036
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	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PETROLATUM (UNII: 4T6H12BN9U)
SHEA BUTTER (UNII: K49155WL9Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONOL (70 CST) (UNII: MOT8IL21AR)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
NEOHESPERIDIN DIHYDROCHALONE (UNII: 3X476D83QV)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CYCLODEXTRINS (UNII: 7E6SK9QDT8)
ADENOSINE (UNII: K72T3FS567)
MOTH BEAN (UNII: H7938ON8E5)
MANNITOL (UNII: 3OWL53L36A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
LAURETH-7 (UNII: Z95S6G8201)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
CETYL ALCOHOL (UNII: 936JST6JCN)
OCTYLDODECANOL (UNII: 461N1O614Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-036-01	1 in 1 CARTON	02/09/2021	02/09/2021
1		50 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 49967-036-02	1 in 1 CARTON	02/09/2021
2		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	02/09/2021

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		624244349	manufacture(49967-036)