THINKBABY SPF 30- zinc oxide stick

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 24%

Purpose

Sunscreen

Uses

• Helps prevent sunburns
• 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.

• 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 liberally 15 minutes before sun exposure.
• Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours when exposed to sun
• 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

For children under 6 months: Ask a doctor

Inactive ingredients

Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Glyceryl Hydrogenated Rosinate, Ricinus Communis (Castor) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis (Aloe) Leaf Powder, Tocopherol, Squalane, Triethoxycaprylylsilane, Beta-Sitosterol, Citric Acid.

Other information

• Protect this product from excessive heat and direct sun.

For Questions

877.446.1616

SPL UNCLASSIFIED SECTION

Dist.by: Think Operations, LLC North Amityville, NY 11701, USA

PRINCIPAL DISPLAY PANEL - 18.4 g Stick Box

ZINC OXIDE
SUNSCREEN STICK

thinkbaby®

30 SPF
0.64 oz 18.4 g

blends in quickly

mineral sunscreen
fragrance-free

INGREDIENTS AND APPEARANCE

THINKBABY  SPF 30
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60781-4490
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	240 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CANDELILLA WAX (UNII: WL0328HX19)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SQUALENE (UNII: 7QWM220FJH)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60781-4490-1	1 in 1 BOX	11/19/2024
1		18 g in 1 APPLICATOR; 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	11/19/2024

Labeler - thinkOperations,LLC (808883636)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(60781-4490)