Drug Facts

Active Ingredients

Titanium dioxide 7.00%

Octocrylene 5.00%

Zinc Oxide 6.00%

Purpose

Sunscreen

Uses:

Helps prevent sunburn.
higher SPF gives more sunburn protection
if used as directed with other sun protection meassures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

For external use only

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 or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

Apply liberally 15 minutes before sun exposure and as needed.
Children under 6 months of age: ask a doctor.
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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
Limit time in the sun, expecially from 10 a.m.-2 p.m.
Wear long-sleevd shirts, pants, hats, and sunglasses.

Other Information:

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

Inactive Ingredients:

Adansonia Digitata (Baobab) Oil, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea Butter), C12-15 Alkyl Benzoate, Caffeine, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Cocos Nucifera (Coconut) Oil, Coffea Arabica Seed Extract, Cymbopogon Flexuosus (Lemongrass) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower Oil), Hyaluronic Acid, Iron Oxides (Black, Red, White, Yellow), Lecithin, Magnesium Aluminum Silicate, Mauritia Flexuosa (Buriti) Oil, Niacinamide, Octyldodecyl Neopentanoate, Ocimum Basilicum (Basil) Extract, Sodium Polyacrylate, Sorbitan Stearate, Ubiquinone (CoQ10), Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol, Zingiber Officinalis (Ginger) Extract, ZIngiber Officinalis (Ginger) Oil,

Questions or comments?

(347-335-5540) Visit us: www.oskinstudionyc.com

Package Labeling:5ml

Outer Package

Package Labeling:50.2ml

Bottle

BB OSKIN BROAD SPECTRUM SPF-30
titanium dioxide, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83276-390
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAFFEINE (UNII: 3G6A5W338E)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DODECANE (UNII: 11A386X1QH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYALURONIC ACID (UNII: S270N0TRQY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
NIACINAMIDE (UNII: 25X51I8RD4)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BASIL (UNII: 2U0KZP0FDW)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
UBIDECARENONE (UNII: EJ27X76M46)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN (UNII: 0N8672707O)
GINGER (UNII: C5529G5JPQ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83276-390-00	5 mL in 1 PACKET; Type 0: Not a Combination Product	02/27/2023
2	NDC:83276-390-01	50.2 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/27/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/27/2023

Labeler - O'Skin Studio NY (014068844)

BB O'SKIN Broad Spectrum SPF-30