BIOSSANCE SQUALANE AND ZINC SHEER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream

Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by THG Beauty USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 17.68%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn.

WARNINGS

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product 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 swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Shake well. Apply generously to face and neck 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. For adult use only.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m.-2p.m ■ wear long-sleeved shirts, pants, hats, and sunglasses.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT

WATER, DICAPRYLYL ETHER, CAPRYLIC/CAPRIC TRIGLYCERIDE, C13-15 ALKANE, POLYGLYCERYL-3 POLYRICINOLEATE, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, COCO-CAPRYLATE, SQUALANE, GLYCERIN, ECTOIN, BISABOLOL, CETYL ALCOHOL, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, HECTORITE, ISOSTEARIC ACID, LECITHIN, POLYHYDROXYSTEARIC ACID, SORBITAN ISOSTEARATE, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, XYLITYLGLUCOSIDE, ANHYDROXYLITOL, XYLITOL, HEDYCHIUM CORONARIUM ROOT EXTRACT, TOCOPHEROL, GLUCOSE.

QUESTIONS

1 833 794 1705

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOSSANCE SQUALANE AND ZINC SHEER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84448-344
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.68 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE (UNII: A5SAE9KW2M)
WATER (UNII: 059QF0KO0R)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
C13-15 ALKANE (UNII: 114P5I43UJ)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOSTEARIC ACID (UNII: X33R8U0062)
SQUALANE (UNII: GW89575KF9)
BISABOLOL (UNII: 24WE03BX2T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
COCO-CAPRYLATE (UNII: 4828G836N6)
VACCINIUM MACROCARPON (CRANBERRY) SEED OIL (UNII: 73KDS3BW5E)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
XYLITOL (UNII: VCQ006KQ1E)
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)
GLUCOSE (UNII: 5SL0G7R0OK)
HECTORITE (UNII: 08X4KI73EZ)
ECTOINE (UNII: 7GXZ3858RY)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84448-344-20	1 in 1 CARTON	07/08/2024
1		20 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84448-344-11	1 in 1 CARTON	07/08/2024
2		100 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 84448-344-50	1 in 1 CARTON	07/08/2024
3		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/08/2024

Labeler - THG Beauty USA LLC (015792160)