SKIN-INFUSED FOUNDATION SPF 25- SHADE BB1 01- zinc oxide, titanium dioxide cream

SKIN-INFUSED FOUNDATION SPF 25- shade BB1 by

Drug Labeling and Warnings

SKIN-INFUSED FOUNDATION SPF 25- shade BB1 by is a Otc medication manufactured, distributed, or labeled by Cosmuses Cosmetics (Ningbo) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Zinc oxide 2.7%

Titanium Dioxide 16.2%

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

WARNINGS

For external use only.

Do not use

Do not use on damaged or broken skin.

Stop use and ask a doctor: if rash occurs.

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

Directions

Apply generously and evenly to face 15 minutes before sun exposure

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 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

Inactive ingredients

water, caprylic/capric triglyceride, aloe barbadensis leaf juice, squalane, simmondsia chinensis (jojoba) seed oil, polyhydroxystearic acid, capryloyl glycerin/sebacic acid copolymer, psoralea corylifolia seed oil, polyglyceryl-6 polyhydroxystearate, polyglyceryl-6 polyricinoleate, magnesium sulfate, glycerin, microcrystalline cellulose, 3-o-ethyl ascorbic acid, niacinamide, sodium chloride, benzyl alcohol, salicylic acid, zinc pca, polyglycerin-6, aluminum stearate, tocopherol, alumina, glycyrrhiza glabra (licorice) root extract, benzoic acid, sorbic acid, citric acid, sodium benzoate, potassium sorbate, ascorbyl palmitate, iron oxides, titanium dioxide

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN-INFUSED FOUNDATION SPF 25- SHADE BB1  01
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.7 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	16.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM SULFITE (UNII: 792J6K230W)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
NIACINAMIDE (UNII: 25X51I8RD4)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID (UNII: 2968PHW8QP)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ALUMINA (UNII: LMI26O6933)
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
SORBIC ACID (UNII: X045WJ989B)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
ZINC PCA (UNII: C32PQ86DH4)
POLYGLYCERIN-6 (UNII: M51422LRAM)
CULLEN CORYLIFOLIUM FRUIT (UNII: 78AD6Z52S6)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-051-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	01/31/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/31/2026

Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-051)