THINKBABY BABY SUNSCREEN SPF 50- zinc oxide lotion

THINKBABY by

Drug Labeling and Warnings

THINKBABY by is a Otc medication manufactured, distributed, or labeled by thinkOperations,LLC, Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 20% (non-nano)

Purpose

Sunscreen

Use

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

Warning

• For external use only.

• Do not use on damaged or broken skin.

• Stop use and ask a doctor if rash occurs.

• When using this product keep out of eyes. Rinse with water to remove.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Protect this product from excessive heat and direct sun.

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

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

Water (Purified), Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C), Capric Caprylic Triglycerides, Cranberry seed oil, Dimethicone, Hyaluraonic acid (made from vegetables), Hydrogenated Castor Oil, Jojoba Oil, Magnesium sulfate (Epsom salt), Methyl abietate (Pine Wood resin), Olive Oil, Polyglercerol-10 Laruate (Vegetable glycerin), Raspberry seed oil, Sorbitan Stearate (coconut based), Sunflower Oil, Tocopherols (Vitamin E), Papaya

Other information

• protect this product from excessive heat and direct sun.

Questions?

877.446.1616

PRINCIPAL DISPLAY PANEL - 89 ml Tube Label

SPF 50+
SUNSCREEN
Active Ingredient: Zinc Oxide 20%

DERMATOLOGIST RECOMMENDED

thinkbaby™

SAFER PRODUCTS FOR HEALTHIER BABIES

WATER RESISTANT (80 MINUTES) BROAD-SPECTRUM SPF 50+

3 fl oz 89ml

The Standard For
Safe Sunscreen

INGREDIENTS AND APPEARANCE

THINKBABY   BABY SUNSCREEN SPF 50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60781-1003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRICAPRIN (UNII: O1PB8EU98M)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PINUS MUGO BARK (UNII: SBJ2CP47EE)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TOCOPHEROL (UNII: R0ZB2556P8)
OLIVE OIL (UNII: 6UYK2W1W1E)
RASPBERRY SEED OIL (UNII: 9S8867952A)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
HYALURONIC ACID (UNII: S270N0TRQY)
PAPAYA (UNII: KU94FIY6JB)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60781-1003-3	89 mL in 1 TUBE; Type 0: Not a Combination Product	08/14/2013
2	NDC: 60781-1003-6	177 mL in 1 TUBE; Type 0: Not a Combination Product	08/14/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/14/2013

Labeler - thinkOperations,LLC (808883636)