BABY MINERAL SUNSCREEN ROLL-ON SPF-30- zinc oxide, titanium dioxide lotion

BABY MINERAL SUNSCREEN ROLL-ON by

Drug Labeling and Warnings

BABY MINERAL SUNSCREEN ROLL-ON by is a Otc medication manufactured, distributed, or labeled by PROJECT SUNSCREEN, VEGE-KURL, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ZINC OXIDE 7%

TITANIUM DIOXIDE 5%

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

KEEP OUT OF REACH OF CHILDREN. IF PRODUCTS IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• SHAKE WELL BEFORE USE
• 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 10AM-2PM
• WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES
• CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

OTHER INFORMATION

• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

INACTIVE INGREDIENTS

WATER, CAPRYLIC CAPRIC TRIGLYCERIDES, C12-15 ALKYL BENZOATE, DICAPRYLYL ETHER, PROPANEDIOL, GLYCERIN, ISOSTEARIC ACID, POLYHYDROXYSTEARIC ACID, PHENOXYETHANOL, BENZOIC ACID, ETHYLHEXYLGLYCERIN, GLYCERETH-2 COCOATE, CETYL PEG/PPG-10/1 DIMETHICONE, OCTYLDODECYL STEARYL CITRATE CROSSPOLYMER, SODIUM CHLORIDE, SODIUM HYALURONATE, TRIETHOXYCAPRYLYLSILANE

QUESTIONS?

CALL 424.262.9462 OR VISIT PROJECTSUNSCREEN.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY MINERAL SUNSCREEN ROLL-ON  SPF-30
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72688-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72688-102-11	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	02/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/08/2019

Labeler - PROJECT SUNSCREEN (080823314)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC.		021072509	manufacture(72688-102)