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

SKINFOOD ALOE SUN BB 02 Natural Skin by

Drug Labeling and Warnings

SKINFOOD ALOE SUN BB 02 Natural Skin by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO.,LTD., IPEERES COSMETICS CO., LTD.. Drug facts, warnings, and ingredients follow.

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 tubeImage of tube

SKINFOOD ALOE SUN BB 02 NATURAL SKIN 
zinc oxide, octinoxate, titanium dioxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76214-068
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.7 g  in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.3 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.7 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76214-068-0150 g in 1 TUBE; Type 0: Not a Combination Product07/15/201611/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/15/201611/01/2019
Labeler - SKINFOOD CO.,LTD. (690324173)
Registrant - SKINFOOD CO.,LTD. (690324173)
Establishment
NameAddressID/FEIBusiness Operations
IPEERES COSMETICS CO., LTD.687590526manufacture(76214-068)

Revised: 12/2019
 
SKINFOOD CO.,LTD.