TOMS BABY SUNSCREEN FRAGRANCE FREE SUNSCREEN- zinc oxide cream

Toms Baby Sunscreen Fragrance Free by

Drug Labeling and Warnings

Toms Baby Sunscreen Fragrance Free by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Zinc oxide 20%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures 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

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

Stop use and ask 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 two 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 a 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-sleeved shirts, pants, hats and sunglasses

Inactive ingredients

caprylic/ capric triglyceride, beeswax, helianthus annuus (sunflower) seed oil, hydrogenated castor oil.

Other information

protect the product in this container from excessive heat and direct sun

Questions?

1-800-FOR TOMS (1-800-367-8667)

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Dist. by Tom's of Maine, Inc., 302 Lafayette Ctr., Kennebunk, ME 04043

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

New!

SINCE 1970
Tom's®
OF MAINE
baby

sunscreen lotion

broad spectrum SPF 30
water resistant (80 minutes)
pediatrician tested
non-nano

fragrance free

natural

• ✓ NO Phthalates
• ✓ NO Parabens
• ✓ NO Phenoxyethanol

NET WT 3 OZ (85g)

INGREDIENTS AND APPEARANCE

TOMS BABY SUNSCREEN FRAGRANCE FREE   SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-702
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-702-85	85 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2015	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2015	10/01/2020

Labeler - Tom's of Maine (052764354)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		061595175	MANUFACTURE(51009-702)