Tubby Todd - (S)UNDERCOVER SPF-50 (73088-106)

(S)UNDERCOVER by

Drug Labeling and Warnings

(S)UNDERCOVER by is a Otc medication manufactured, distributed, or labeled by TUBBY TODD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

(S)UNDERCOVER SPF 50- zinc oxide lotion 
TUBBY TODD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Tubby Todd - (S)UNDERCOVER SPF-50 (73088-106)

ACTIVE INGREDIENTS

Zinc Oxide 12%

PURPOSE

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.

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 15 minutes before sun exposure and as needed.
• Reapply
• after 40 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10am-2pm
• wear long-sleeved shirts, pants, hats, and sunglasses.

OTHER INFORMATION

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENT

ALLANTOIN, BISABOLOL, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, COCO-CAPRYLATE, HELIANTHUS ANNUUS (SUNFLOWER) EXTRACT, JOJOBA ESTERS, LECITHIN, METHYLHEPTYL ISOSTEARATE, METHYLPROPANEDIOL, NIACINAMIDE, NYLON-12, ORYZA SATIVA (RICE) BRAN EXTRACT, PHENYLPROPANOL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, PROPANEDIOL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, SILICA, SODIUM CHLORIDE, TETRASODIUM GLUTAMATE DIACETATE, TRIDECYL SALICYLATE, TOCOPHEROL, WATER

QUESTIONS

(619) 894-6560

(S)UNDERCOVER  SPF 50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73088-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)	Â
WATER (UNII: 059QF0KO0R)	Â
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	Â
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)	Â
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	Â
COCO-CAPRYLATE (UNII: 4828G836N6)	Â
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)	Â
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) (UNII: AS2SZ9757N)	Â
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)	Â
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)	Â
PHENYLPROPANOL (UNII: 0F897O3O4M)	Â
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)	Â
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)	Â
PROPANEDIOL (UNII: 5965N8W85T)	Â
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)	Â
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	Â
SODIUM CHLORIDE (UNII: 451W47IQ8X)	Â
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	Â
NYLON-12 (UNII: 446U8J075B)	Â
RICE BRAN (UNII: R60QEP13IC)	Â
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)	Â
NIACINAMIDE (UNII: 25X51I8RD4)	Â
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)	Â

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73088-106-12	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/14/2022

Labeler - TUBBY TODD (052545299)

Revised: 4/2022

Document Id: dca478a0-c318-68d8-e053-2a95a90a10fc

34390-5

Set id: dca478a0-c319-68d8-e053-2a95a90a10fc

Version: 1

Effective Time: 20220414

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