REVITALIZING MOISTURIZING SUNSCREEN SPF 20- octocrylene and octinoxate and avobenzone cream 
GENOME COSMETICS, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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REVITALIZING MOISTURIZING SUNSCREEN CREAM - SPF-20

Active ingredient

OCTOCRYLENE 10.0%

OCTINOXATE 7.5%

AVOBENZONE 3.0%

Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not apply to

Warnings

Consult a doctor

Warnings

Stop use

Keep Out of Reach of Children.

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

Directions

Other Information

Inactive Ingredients

Water (AQUA, EAU), Helianthus Annuus Seed Oil, Cetearyl Alcohol, Limnanthes Alba, Carthamus Tinctorius (SAFFLOWER) Seed Oil, Meadowfoam Estolide, Polysorbate-60, Crambe Abyssinica Seed Oil, Simmondsia Chinesis (JOJOBA) Seed Oil, Meadowfoam Delta-Lactone, Olea Europaea (OLIVE) Oil Unsaponifiables, PEG-40 Hydrogenated Castor Oil, Meadowfoamamidopropyl Betaine, Dimethicone PEG-8 Meadowfoamate, Steareth-20, Polysorbate-65, Phenoxyethanol, Carbomer, Panthenol, Phytosterol, Aminomethylpropanol, CI15985 (YELLOW 6), Tocopheryl Acetate, Fragrance (Parfum), Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Cholecalciferol, Calendula Officinalis Flower Extract, Anthemis Nobilis (CHAMOMILE) Flower Extract, Beta Sitosterol, Tripeptide-10 Citrulline, Ubiquinone Q10, Sea Salt, Glycine Soja (Soybean) Oil, Oenothera Biennis (EVENING PRIMROSE) Oil (OMEGA-3), Borago Officinalis (BORAGE) Seed Oil (OMEGA-6), Aloe Barbadensis Leaf Juice, Algae Extract, Hippophae Rhamnoides (SEA BUCKTHORN) Extract. PARABEN-FREE

Package/Label Principal Display Panel

DARK & BEAUTY REVITALIZING MOISTURIZING CREAM SPF-20

Manufactured for and exclusively distributed by:

Genome Cosmetics LLC

Bensalem, PA 19020 USA

Made in the U.S.A

Age Control Label

Carton Label

REVITALIZING MOISTURIZING SUNSCREEN SPF 20 
octocrylene and octinoxate and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61791-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LIMNANTHES ALBA WHOLE (UNII: DKY81513ER)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
MEADOWFOAM SEED OIL FATTY ACIDS (UNII: MK2D1PBV6N)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
JOJOBA OIL (UNII: 724GKU717M)  
MEADOWLACTONE (UNII: 3OY5Q13U9R)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
MEADOWFOAMAMIDOPROPYL BETAINE (UNII: HNV0L650LG)  
STEARETH-20 (UNII: L0Q8IK9E08)  
POLYSORBATE 65 (UNII: 14BGY2Y3MJ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
PANTHENOL (UNII: WV9CM0O67Z)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
TRIPEPTIDE-10 CITRULLINE (UNII: 2732R0E76W)  
UBIDECARENONE (UNII: EJ27X76M46)  
SEA SALT (UNII: 87GE52P74G)  
GLYCINE (UNII: TE7660XO1C)  
SOYBEAN OIL (UNII: 241ATL177A)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
BORAGE OIL (UNII: F8XAG1755S)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NORI (UNII: 477TV3P5UX)  
HIPPOPHAE RHAMNOIDES FRUIT JUICE (UNII: UC3P08EB3Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61791-126-011 in 1 CARTON
150 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/02/2015
Labeler - GENOME COSMETICS, LLC (013538977)
Establishment
NameAddressID/FEIBusiness Operations
RNA PHARMA, LLC079103999manufacture(61791-126)

Revised: 10/2013
Document Id: 55bcafbe-c613-4ab5-809d-d601838882b3
Set id: b8d39629-8729-44ae-97d6-bbb219e3bdfd
Version: 1
Effective Time: 20131022
 
GENOME COSMETICS, LLC