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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE 7%, TITANIUM DIOXIDE 5%
Available from:
PROJECT SUNSCREEN
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
SUNSCREEN - 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.
Authorization status:
OTC monograph not final
Authorization number:
72688-102-11

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

PROJECT SUNSCREEN

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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PROJECT SUNSCREEN BABY MINERAL SUNSCREEN ROLL-ON LOTION

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. 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

BABY MINERAL SUNSCREEN ROLL-ON SPF-30

zinc oxide, titanium dioxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:726 8 8 -10 2

Route of Administration

TOPICAL

PROJECT SUNSCREEN

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

7 g in 10 0 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

DICAPRYLYL ETHER (UNII: 77JZM5516 Z)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

GLYCERIN (UNII: PDC6 A3C0 OX)

ISO STEARIC ACID (UNII: X33R8 U0 0 6 2)

PO LYHYDRO XYSTEARIC ACID ( 2 3 0 0 MW) (UNII: YXH47AOU0 F)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GLYCERETH-2 CO CO ATE (UNII: JWM0 0 VS7HC)

CETYL PEG/PPG-10 /1 DIMETHICO NE ( HLB 1.5) (UNII: V2W71V8 T0 X)

O CTYLDO DECYL STEARATE (UNII: K6 F16 QGO28 )

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:726 8 8 -

10 2-11

8 5 g in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/0 8 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 2/0 8 /20 19

Labeler -

PROJECT SUNSCREEN (080823314)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

VEGE-KURL, INC.

0 210 7250 9

ma nufa c ture (726 8 8 -10 2)

Revised: 3/2019

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