REVITALIZING MOISTURIZING SUNSCREEN SPF 20- octocrylene and octinoxate and avobenzone cream

REVITALIZING MOISTURIZING Sunscreen SPF 20 by

Drug Labeling and Warnings

REVITALIZING MOISTURIZING Sunscreen SPF 20 by is a Otc medication manufactured, distributed, or labeled by GENOME COSMETICS, LLC, RNA PHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

OCTOCRYLENE 10.0%

OCTINOXATE 7.5%

AVOBENZONE 3.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

For external use only.

Do not apply to

• irritated or broken skin.

Warnings

Consult a doctor

• Stop use and consult a doctor if rash occurs.

Warnings

Stop use

• Stop use and consult 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

• Gently massage onto all areas of the face using a circular motion 15 minutes prior

  to sun exposure

• Reapply every two hours
• For children under 6 months of age, ask a doctor
• Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.

Other Information

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

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

Carton Label

INGREDIENTS AND APPEARANCE

REVITALIZING MOISTURIZING SUNSCREEN SPF 20 
octocrylene and octinoxate and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61791-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61791-126-01	1 in 1 CARTON
1		50 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/02/2015

Labeler - GENOME COSMETICS, LLC (013538977)

Establishment
Name	Address	ID/FEI	Business Operations
RNA PHARMA, LLC		079103999	manufacture(61791-126)