BUBBLE SOLAR MATE DAILY MINERAL SUNSCREEN SPF 40- zinc oxide cream

Bubble Solar Mate Daily Mineral Sunscreen SPF 40 by

Drug Labeling and Warnings

Bubble Solar Mate Daily Mineral Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION, COSMAX USA. CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Zinc Oxide 12%

PURPOSE

Purpose

Sunscreen

USES

Uses

• helps prevent sunburn

Warnings

Warnings

For extenal use only

Do not useon damaged or broken skin

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

Stop use and ask a doctor ifrash occurs

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

DIRECTIONS

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months of age: Ask a doctor

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. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.

OTHER INFORMATION

Other information

• Protect the product in this container from excessive heat and direct sun
• Avoid storing at extreme temperatures (Below 40F and above 100F)
• In case of serious adverse effects, please call + (651) 504-2243

INACTIVE INGREDIENT

Inactive ingredientsWater (Aqua), Isoamyl Laurate, Glycerin, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-10 Stearate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Cetearyl Olivate, Sorbitan Olivate, Rubus Idaeus (Raspberry) Seed Oil, Panax Ginseng Root Extract, Theobroma Cacao (Cocoa) Seed Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyacetophenone, Polyglyceryl-10 Laurate, Microcrystalline Cellulose, Butylene Glycol, Xanthan Gum, Cellulose Gum, Phenoxyethanol.

QUESTIONS or COMMENTS

Questions or comments?

Call+1 (651) 504-2243

PRINCIPAL DISPLAY PANEL

Primary Package(Inner)

PRINCIPAL DISPLAY PANEL

Outer Package (Secondary)

INGREDIENTS AND APPEARANCE

BUBBLE SOLAR MATE DAILY MINERAL SUNSCREEN SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ISOAMYL LAURATE (UNII: M1SLX00M3M)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
RASPBERRY SEED OIL (UNII: 9S8867952A)
ASIAN GINSENG (UNII: CUQ3A77YXI)
COCOA (UNII: D9108TZ9KG)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
WATER (UNII: 059QF0KO0R)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-156-01	1 in 1 CARTON	06/01/2023
1		50 mg 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	06/01/2023

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA. CORPORATION		010990210	manufacture(68577-156)