BB CREAM BROAD SPECTRUM SPF 25 MEDIUM 01- zinc oxide cream

BB Cream Broad Spectrum SPF 25 Medium 01 by

Drug Labeling and Warnings

BB Cream Broad Spectrum SPF 25 Medium 01 by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide 21.0%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses:

• Helps prevent sunburn.
• If used as directed with other sun protection measures, decreases the risk of skin cancer and  early skin aging  caused by the sun.
  

WARNINGS AND PRECAUTIONS

Warning: For external use only.

DO NOT USE

Do not use: on damaged or broken skin.

WHEN USING

When using this products:

• Keep out of eyes.
• Rinse with water to remove.
  

STOP USE

Stop use and ask a doctor: If rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

• If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

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

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

FLOETIC BEAUTY LLC, DIST.

CLYDE HILL, WA 98004

MADE IN USA

WWW.FLOETICBEAUTY.COM

INGREDIENTS AND APPEARANCE

BB CREAM BROAD SPECTRUM SPF 25 MEDIUM 01 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4180
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: 62742-4180-2	1 in 1 CARTON	12/09/2019
1	NDC: 62742-4180-1	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)