THINK KIDS MINERAL SPF 50- zinc oxide and titanium dioxide aerosol, spray

Think Kids Mineral by

Drug Labeling and Warnings

Think Kids Mineral by is a Otc medication manufactured, distributed, or labeled by thinkOperations,LLC, Topiderm, Inc., Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
Titanium Dioxide 3.4%	Sunscreen
Zinc Oxide 15.7%	Sunscreen

Uses

• 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 the sun

Warnings

For external use only

Contents Under Pressure. Do not puncture or incinerate can. Do not store at temperatures above 120°F

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Shake well, apply liberally and evenly 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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 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, Butyloctyl Salicylate, Dicaprylyl Carbonate, Isononyl Isononanoate, Propanediol, Isocetyl Stearoyl Stearate, Methyl Dihydroabietate, Cetearyl Alcohol, Aloe Barbadensis Leaf Juice, Musa Sapientum (Banana) Fruit Extract, Bentonite, Glycerin, Tocopherol, Citric Acid, Alumina, Sodium Gluconate, Bisabolol, Caprylhydroxamic Acid, Cellulose Gum, Caprylyl Glycol, Coco-Glucoside, Microcrystalline Cellulose, Polyhydroxystearic Acid, Polyester-8, Silica, Sodium Stearoyl Glutamate, C18-21 Alkane.

Other Information

• protect this product from excessive heat and direct sun

For Questions

877.446.1616

SPL UNCLASSIFIED SECTION

Dist.by: Think Operations, LLC
Simi Valley, CA 93065 USA

PRINCIPAL DISPLAY PANEL - 177 ml Canister Label

thinkkids

reef friendly

80
min
water
resistant

ALL SHEER MINERAL
SUNSCREEN SPRAY

50 SPF

broad spectrum SPF 50
dermatologist tested
safe for sensitive skin
no-fuss application
air-powered spray

6 fl oz 177 ml

INGREDIENTS AND APPEARANCE

THINK KIDS MINERAL   SPF 50
zinc oxide and titanium dioxide aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60781-4700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	157 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	34 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PROPANEDIOL (UNII: 5965N8W85T)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
METHYL DEHYDROABIETATE (UNII: 4P47O55S2W)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BANANA (UNII: 4AJZ4765R9)
BENTONITE (UNII: A3N5ZCN45C)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM GLUCONATE (UNII: R6Q3791S76)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO GLUCOSIDE (UNII: ICS790225B)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
C18-C21 ALKANE (UNII: 33822S0M40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60781-4700-1	177 mL in 1 CANISTER; Type 0: Not a Combination Product	05/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/30/2023

Labeler - thinkOperations,LLC (808883636)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	MANUFACTURE(60781-4700)