BB CREAM BROAD SPECTRUM SPF 25 LIGHT 01- zinc oxide cream 
Allure Labs Inc

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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DRUG FACTS

Active Ingredients:

Zinc Oxide 21.0%

Purpose: Sunscreen

Uses:

Warning: For external use only.

Do not use: on damaged or broken skin.

When using this products:

Stop use and ask a doctor: If rash occurs.

Keep out of reach of children:

Directions:

Protect the product in this container from excessive heat and direct sun.

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).

FLOETIC BEAUTY LLC, DIST.

CLYDE HILL, WA 98004

MADE IN USA

WWW.FLOETICBEAUTY.COM

BB Cream BS SPF 25 Light 01

BB CREAM BROAD SPECTRUM SPF 25 LIGHT 01 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4178
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE210 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4178-21 in 1 CARTON11/21/2019
1NDC:62742-4178-120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/21/2019
Labeler - Allure Labs Inc (926831603)

Revised: 11/2019
Document Id: 9b2d6c00-97a5-4c6a-91d0-0080c09f2a5c
Set id: fa86fc6d-41ae-45a3-8d0d-bdafb2a0e5f2
Version: 1
Effective Time: 20191121
 
Allure Labs Inc