BIOSSANCE SQUALANE AND DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide cream

Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50 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

Titanium Dioxide 5.14%

Zinc Oxide 5.74%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

WARNINGS

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

STOP USE

Stop use and ask a doctor if rash occurs.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

DOSAGE & ADMINISTRATION

• Shake well before use.
• Apply generously to face and neck 15 minutes before sun exposure.
• Use water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• 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 Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses.

• Children under 6 months of age: Ask a doctor.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, PENTYLENE GLYCOL, GLYCERIN, SQUALANE, SILICA, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALUMINA, HYDROGENATED LECITHIN, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PROPANEDIOL, STEARIC ACID, NIACINAMIDE, JOJOBA ESTERS, 1,2-HEXANEDIOL, ALLANTOIN, TOCOPHERYL ACETATE, XANTHAN GUM, GLYCINE SOJA (SOYBEAN) OIL, SODIUM HYALURONATE, TOCOPHEROL, GLYCOGEN, ETHYLHEXYLGLYCERIN, CAPRYLHYDROXAMIC ACID, SORBITAN ISOSTEARATE, CITRIC ACID, SODIUM HYDROXIDE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOSSANCE SQUALANE AND DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84448-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.74 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.1359 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
NIACINAMIDE (UNII: 25X51I8RD4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ALUMINA (UNII: LMI26O6933)
SILICA (UNII: ETJ7Z6XBU4)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SQUALANE (UNII: GW89575KF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)
SOYBEAN OIL (UNII: 241ATL177A)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCOGEN (UNII: 309GSC92U1)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CITRIC ACID (UNII: 2968PHW8QP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84448-801-12	1 in 1 CARTON	01/01/2026
1		120 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84448-801-60	1 in 1 CARTON	01/01/2026
2		60 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 84448-801-30	1 in 1 CARTON	01/01/2026
3		30 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	01/01/2026

Labeler - THG Beauty USA LLC (015792160)