OTC Medication Information: BB Cream Broad Spectrum SPF 25 Light 01

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.

Active Ingredients:

Zinc Oxide 21.0%

Purpose: Sunscreen

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.
  

Warning: For external use only.

Do not use: on damaged or broken skin.

When using this products:

• 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 medical help or contact a Poison Control Center right away.

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 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 BROAD SPECTRUM SPF 25 LIGHT 01 zinc oxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4178 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 210 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER MEDIUM-CHAIN TRIGLYCERIDES COCONUT ALKANES CETOSTEARYL ALCOHOL GLYCERIN ALOE VERA LEAF GLYCERYL MONOSTEARATE PEG-100 STEARATE COCO GLUCOSIDE SUNFLOWER OIL PHYTATE SODIUM ALCOHOL CAPRYLYL/CAPRYL OLIGOGLUCOSIDE BETASIZOFIRAN XANTHAN GUM POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-3 RICINOLEATE ISOSTEARIC ACID LECITHIN, SOYBEAN APPLE CETEARYL GLUCOSIDE TETRAHEXYLDECYL ASCORBATE SHEA BUTTER COCO-CAPRYLATE/CAPRATE TOCOPHEROL HYALURONATE SODIUM PHENOXYETHANOL ETHYLHEXYLGLYCERIN POLYACRYLAMIDE (10000 MW) C13-14 ISOPARAFFIN LAURETH-7 HYDROLYZED JOJOBA ESTERS (ACID FORM) CITRIC ACID MONOHYDRATE CHAMAEMELUM NOBILE FLOWER CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF TRIETHOXYCAPRYLYLSILANE DIMETHICONE LIMONENE, (+)- LINALOOL, (+/-)- MICA TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62742-4178-2 1 BOTTLE in 1 CARTON contains a BOTTLE (62742-4178-1) 1 NDC:62742-4178-1 20 mL in 1 BOTTLE This package is contained within the CARTON (62742-4178-2)

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)

Revised: 11/2019 Allure Labs Inc