SKINCEUTICALS DAILY BRIGHTENING UV DEFENSE BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

SkinCeuticals Daily Brightening UV Defense Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

SkinCeuticals Daily Brightening UV Defense Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

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

● 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, silica, dimethicone, niacinamide, alcohol denat., titanium dioxide, PEG-100 stearate, glyceryl stearate, mica, tranexamic acid, stearic acid, phenoxyethanol, citric acid, palmitic acid, ammonium polyacryloyldimethyl taurate, hydroxyacetophenone, dicaprylyl carbonate, steareth-100, phenylethyl resorcinol, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, trisodium ethylenediamine disuccinate, synthetic fluorphlogopite, tocopherol, sodium hyaluronate, cymbopogon schoenanthus oil, citral, myristic acid, iron oxides, tin oxide, geraniol, limonene, linalool, citronellol

Questions or comments?

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKINCEUTICALS DAILY BRIGHTENING UV DEFENSE BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-861
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	72 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MICA (UNII: V8A1AW0880)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PALMITIC ACID (UNII: 2V16EO95H1)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STEARETH-100 (UNII: 4OH5W9UM87)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
CITRAL (UNII: T7EU0O9VPP)
MYRISTIC ACID (UNII: 0I3V7S25AW)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STANNIC OXIDE (UNII: KM7N50LOS6)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-861-01	1 in 1 CARTON	04/01/2021
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-861-02	4 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2021

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		172198223	manufacture(49967-861)