AMERICAN CREW ALL IN ONE FACE BALM BROAD SPECTRUM SPF 15- octisalate,homosalate,avobenzone,octocrylene liquid

American Crew All In One Face Balm Broad Spectrum SPF 15 by

Drug Labeling and Warnings

American Crew All In One Face Balm Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Revlon Consumer Products Corp, REVLON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octisalate 5.0%

Homosalate 5.0%

Avobenzone 2.0%

Octocrylene 2.0%

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 notuse 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 a rash occurs
Keep out of reach of children. If product is 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: 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 am - 2 pm
Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Aqua/Water/Eau, C12-15 Alkyl Benzoate, Squalane,
Glycerin, Dimethicone, Cetearyl Alcohol, Behentrimonium
Chloride, Polyquaternium-37, Bisabolol, Panthenol,
Hydroxyacetophenone, Glyceryl Dibehenate, Allantoin,
Tocopheryl Acetate, Tribehenin, Glyceryl Behenate,
Farnesol, Disodium EDTA, Sodium Citrate, Dipotassium
Glycyrrhizate, Dimethicone Crosspolymer, Saccharide
Isomerate, Parfum (Fragrance), Caprylyl Glycol,
1,2-Hexanediol, Phenoxyethanol, Hydroxycitronellal,

Questions?

1-800-598-2739

PRINCIPAL DISPLAY PANEL

American Crew All in One Face Balm

Broad Spectrum SPF 15

170mL

PRINCIPAL DISPLAY PANEL

American Crew All in One Face Balm

Broad Spectrum SPF 15

50mL

INGREDIENTS AND APPEARANCE

AMERICAN CREW ALL IN ONE FACE BALM BROAD SPECTRUM SPF 15 
octisalate,homosalate,avobenzone,octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-651
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SQUALANE (UNII: GW89575KF9)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
4-HYDROXY ACETOPHENONE (UNII: G1L3HT4CMH)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
FARNESOL (UNII: EB41QIU6JL)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
EUGENOL (UNII: 3T8H1794QW)
GERANIOL (UNII: L837108USY)
BENZYL BENZOATE (UNII: N863NB338G)
CITRAL (UNII: T7EU0O9VPP)
CINNAMYL ALCOHOL (UNII: SS8YOP444F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-651-51	170 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2017
2	NDC: 10967-651-24	50 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2017

Labeler - Revlon Consumer Products Corp (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
REVLON, INC.		809725570	manufacture(10967-651)