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 Bubble Beauty, Inc., Paklab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Zinc Oxide 12%

Purpose

Sunscreen

Uses:

Helps prevent sunburn

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 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 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

• Protect the product in this container from excessive heat and direct sun
• Avoid storing at extreme temperatures (Below 40°F and above 100°F).
• In case of serious adverse effects, please call +1 (651) 504-2243

Inactive ingredients

Water (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?

Call+1(651) 504-2243

Package Labeling:

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: 83509-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
RASPBERRY SEED OIL (UNII: 9S8867952A)
ASIAN GINSENG (UNII: CUQ3A77YXI)
COCOA (UNII: D9108TZ9KG)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XANTHAN GUM (UNII: TTV12P4NEE)
CELLULOSE GUM (UNII: K679OBS311)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83509-156-01	1 in 1 CARTON	06/01/2023
1		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	06/01/2023

Labeler - Bubble Beauty, Inc. (117396016)

Registrant - Paklab (177711082)