BROAD SPECTRUM MOISTURIZING SUNSCREEN-SPF 15, OCTINOXATE, OXYBENZONE- octinoxate, oxybenzone lotion

Broad Spectrum Moisturizing Sunscreen-SPF 15, Octinoxate, Oxybenzone by

Drug Labeling and Warnings

Broad Spectrum Moisturizing Sunscreen-SPF 15, Octinoxate, Oxybenzone by is a Otc medication manufactured, distributed, or labeled by Only Yourx, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Octinoxate (Octyl Methoxycinnamate), Oxybenzone

INACTIVE INGREDIENT

Other Ingredients: Water, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Allantoin, Aloe Vera Powder, D-Panthenol, Sodium Edetate, Squalane, Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60, Phenoxyethanol, Ethylhexylglycerin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroethylacrylate/Sodium Acryloyldimethyl Copolymer, Aminomethylpropanol

DOSAGE & ADMINISTRATION

USE INSTRUCTIONS: Apply a liberal amount aproximately 30 minutes prior to sun exposure. For continuous protection, reapply regularly and after swimming and/or exercising

INDICATIONS & USAGE

Broad spectrum UVA and UVB protection. Lightweight lotion suitable for even oily skin helps to protect damaging rays, moisture loss and premature aging of the skin

PURPOSE

Broad spectrum UVA and UVB protection

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center immediately.

WARNINGS

Warnings: For external use only; Do not use on damaged or broken skin; Stop use and ask a doctor if rash occurs; When using this product keep out of eyes; Rinse with water to remove

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM MOISTURIZING SUNSCREEN-SPF 15, OCTINOXATE, OXYBENZONE 
octinoxate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70367-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
SQUALANE (UNII: GW89575KF9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
LAURYL LACTATE (UNII: G5SU0BFK7O)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ALLANTOIN (UNII: 344S277G0Z)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70367-006-04	120 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
2	NDC: 70367-006-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/26/2014

Labeler - Only Yourx, Inc. (089207519)