SUNSCREEN SPF-50- zinc oxide stick

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

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Active ingredient:
ZINC OXIDE 22.5%
Available from:
SALT AND STONE
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
SUNSCREEN - HELPS PREVENT SUNBURN
Authorization status:
OTC monograph not final
Authorization number:
71585-104-11

SUNSCREEN SPF-50- zinc oxide stick

SALT AND STONE

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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MINERAL BASED SALT & STONE PREMIUM SUNSCREEN FACE STICK SPF-50

ACTIVE INGREDIENTS

ZINC OXIDE 22.5%

PURPOSE

SUNSCREEN

USES

HELPS PREVENT SUNBURN

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 PRODUCT IS SWALLOWED, GET MEDICAL HELP

OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

FOR USE ON CHILDREN LESS THAN 6 MONTHS OF AGE, CONSULT A HEALTH CARE

PRACTITIONER. APPLY LIBERALLY/GENEROUSLY (AND EVENLY) 15 MINUTES BEFORE

SUN EXPOSURE. REAPPL AFTER 80 MINUTES OF SWIMMING OR SWEATING OR

IMMEDIATELY AFTER TOWEL DRYING. REAPPLY 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

SUN SCREEN WITH A BROAD SPECTRUM OF SPF 15 OR HIGHER AND OTHER SUN

PROTECTION MEASURES INCLUDING:

LIMIT TIME IN THE SUN, FROM 10 A.M. - 2 P.M.

WEAR LONG-SLEEVE SHIRTS, PANTS, HATS, AND SUNGLASSES

CHILDREN UNDER 6 MONTHS: ASK A DOCTOR

INACTIVE INGREDIENTS

* TYROSPERMUM PARKII (SHEA) BUTTER, * BEESWAX (CIRE D'ABIELLE), * COCOS

NUCIFERA (COCONUT) OIL, SILICA, * COPERNICIA PRUNIFERA (CARNAUBA) WAX,*

HELIANTHUS ANNUUS (SUNFLOWER) OIL, IRON OXIDE, MICA, SILICA, * SIMMONDSIA

CHINENSIS (JOJOBA) OIL, * THEOBROMA CACAO (COCOA) BUTTER, VITAMIN E.

* CERTIFIED ORGANIC

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

QUESTIONS OR COMMENTS?

CALL TOLL FREE 1 888 952 4250

SUNSCREEN SPF-50

zinc oxide stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7158 5-10 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

ZINC CATION

22.5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

SHEA BUTTER (UNII: K49 155WL9 Y)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

MICA (UNII: V8 A1AW0 8 8 0 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

JO JO BA O IL (UNII: 724GKU717M)

SALT AND STONE

CO CO A BUTTER (UNII: 512OYT1CRR)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7158 5-10 4-11

15 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /29 /20 17

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 8 /29 /20 17

Labeler -

SALT AND ST ONE (080683697)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Filltech USA, LLC

9 26 4338 55

ma nufa c ture (7158 5-10 4)

Revised: 4/2019

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