BROAD SPECTRUM MOISTURIZING SUNSCREEN SPF 30- octinoxate, zinc oxide, octisalate, oxybenzone lotion

Broad Spectrum Moisturizing Sunscreen SPF 30 by

Drug Labeling and Warnings

Broad Spectrum Moisturizing Sunscreen SPF 30 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, Zinc Oxide, Octisalate, Oxybenzone

INACTIVE INGREDIENT

Other Ingredients: Water, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Glycerin, Stearyl Alcohol, Cetyl Alcohol, Squalane, Polysorbate 60, Vitamin E Tocopheryl Acetate, Pine Bark Extract, Japanese Green Tea Extract, Rosehips Extract, Licorice Extract, Sodium Edetate, Xanthan Gum, Magnesium Aluminum Silicate, Phenoxyethanol, Ethylhexyiglycerin, Hydroethylacrylate/Sodium Acryloldimethyl Copolymer, Fragrance

OTHER SAFETY INFORMATION

Suitable for normal to dry skin

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

Vitamin-enriched formula skin-aging UVA/UVB rays with advanced, broad-spectrum sunscreens and powerful antioxidants. Helps prevent moisture loss and premature aging of the skin.

PURPOSE

Broad spectrum UVA and UVB protection.

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;

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children; If swallowed, get medical help or contact a Poison Control Center immediately

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM MOISTURIZING SUNSCREEN SPF 30 
octinoxate, zinc oxide, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70367-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.2 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LICORICE (UNII: 61ZBX54883)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
LAURYL LACTATE (UNII: G5SU0BFK7O)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70367-005-04	120 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
2	NDC: 70367-005-01	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)