ALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS- zinc oxide, octinoxate, titanium dioxide, octisalate cream

ALOE SUN BB by

Drug Labeling and Warnings

ALOE SUN BB by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: ZINC OXIDE 5.41%, ETHYLHEXYL METHOXYCINNAMATE 5.00%, TITANIUM DIOXIDE 4.73%, ETHYLHEXYL SALICYLATE 3.50%

INACTIVE INGREDIENT

Inactive ingredient:
WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, NIACINAMIDE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, TRIMETHYLSILOXYSILICATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, SORBITAN ISOSTEARATE, PROPYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, STEARIC ACID, BEESWAX, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER , DIMETHICONE, ALUMINA, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, OZOKERITE, TALC, PROPYLENE CARBONATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA SILYLATE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE/METHICONE COPOLYMER, HYALURONIC ACID, SILICA, ADENOSINE, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

PURPOSE

PURPOSE: Sunscreen

WARNINGS

Warning: Skin Cancer/Skin Aging Alert
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only. Do not use 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 rash occurs. Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

USE

USE:
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

DIRECTIONS

DIRECTIONS:
Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE SUN BB  SPF50 PLUS PA PLUS PLUS PLUS
zinc oxide, octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.70 g  in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.50 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.36 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.75 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-046-01	50 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2014

Labeler - SKINFOOD CO., LTD. (690324173)

Registrant - SKINFOOD CO., LTD. (690324173)

Establishment
Name	Address	ID/FEI	Business Operations
SKINFOOD CO., LTD.		690324173	manufacture(76214-046)