SKINFOOD ALOE SUN BB 02 Natural Skin by SKINFOOD CO.,LTD. / IPEERES COSMETICS CO., LTD.

Drug Details [pdf]

SKINFOOD ALOE SUN BB 02 NATURAL SKIN- zinc oxide, octinoxate, titanium dioxide, octisalate cream
SKINFOOD CO.,LTD.

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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ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

Inactive Ingredients: 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, SODIUM HYALURONATE, SILICA, ADENOSINE, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 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 medicalhelp or contact a Poison Control Center right away.

DESCRIPTION

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: 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

Image of tube

SKINFOOD ALOE SUN BB 02 NATURAL SKIN
zinc oxide, octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-068
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.7 g in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.3 g in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.7 g in 50 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 76214-068-01	50 g in 1 TUBE; Type 0: Not a Combination Product	07/15/2016	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/15/2016	11/01/2019

Labeler - SKINFOOD CO.,LTD. (690324173)

Registrant - SKINFOOD CO.,LTD. (690324173)

Name	Address	ID/FEI	Business Operations
Establishment
IPEERES COSMETICS CO., LTD.		687590526	manufacture(76214-068)

Revised: 12/2019

Document Id: 3142a6c5-40a3-459a-b336-9be4a2c5c2a0

Set id: 702f4af6-e8ea-45b5-a4a6-3e4dd0b3a415

Version: 2

Effective Time: 20191226

SKINFOOD CO.,LTD.