Label: BB CREAM BROAD SPECTRUM SPF 25 LIGHT 01- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4178-1, 62742-4178-2 - Packager: Allure Labs Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 21, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
- Apply generously 15 minutes before sun exposer.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating. Immediatly after towel drying. at least every 2 hours.
- Sun protection measures.Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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 sleeve shirts, pants, hats and sunglasses.
- Children under 6 months: ask a doctor.
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INACTIVE INGREDIENT
Inactive Ingredients: Water (Aqua), Caprylyc/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Glyceryl Stearate, PEG-100 Stearate, Coco-Glucoside, Helianthus Annus, Caprylyl/Capryl Glucoside, Sclerotium Gum, Xanthan Gum, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Pyrus Malus (Apple) Fruit Extract, Cetearyl Glucoside, Tetrahexyldecyl Ascorbate, Butyrospermum Parkii (Shea) Butter, Coco-Caprylate/Caprate, Tocopherol, Sodium Hyaluronate, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth 7, Hydrolyzed Jojoba Esters, Citric Acid, Anthemis Nobilis Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Extract, Triethoxycaprylylsilane, Dimethicone, Fragrance, Limonene, Linalool, May contain +/-, Mica (Cl 77019), Titanium Dioxide (Cl 77891), Iron Oxides (Cl77491, Cl77492, Cl 77499).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BB CREAM BROAD SPECTRUM SPF 25 LIGHT 01
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4178 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 210 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCONUT ALKANES (UNII: 1E5KJY107T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) COCO GLUCOSIDE (UNII: ICS790225B) SUNFLOWER OIL (UNII: 3W1JG795YI) PHYTATE SODIUM (UNII: 88496G1ERL) ALCOHOL (UNII: 3K9958V90M) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) BETASIZOFIRAN (UNII: 2X51AD1X3T) XANTHAN GUM (UNII: TTV12P4NEE) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) ISOSTEARIC ACID (UNII: X33R8U0062) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) APPLE (UNII: B423VGH5S9) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) SHEA BUTTER (UNII: K49155WL9Y) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TOCOPHEROL (UNII: R0ZB2556P8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4178-2 1 in 1 CARTON 11/21/2019 1 NDC:62742-4178-1 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/21/2019 Labeler - Allure Labs Inc (926831603)
