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NDC 73088-0106-12 (S)UNDERCOVER 12 g/100mL Details

(S)UNDERCOVER 12 g/100mL

(S)UNDERCOVER is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by TUBBY TODD. The primary component is ZINC OXIDE.

Product Information

NDC	73088-0106
Product ID	73088-106_dca478a0-c318-68d8-e053-2a95a90a10fc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	(S)UNDERCOVER
Proprietary Name Suffix	SPF 50
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	12
Active Ingredient Units	g/100mL
Substance Name	ZINC OXIDE
Labeler Name	TUBBY TODD
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 73088-0106-12 (73088010612)

Pricing Information	N/A
NDC Package Code	73088-106-12
Billing NDC	73088010612
Package	50 mL in 1 BOTTLE (73088-106-12)
Marketing Start Date	2022-04-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dca478a0-c319-68d8-e053-2a95a90a10fc Details

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.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

(S)UNDERCOVER SPF 50

zinc oxide lotion

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

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

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

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

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

Labeler - TUBBY TODD (052545299)

Revised: 4/2022

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

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

Version: 1

Effective Time: 20220414