PREMIUM SUNSCREEN SPF-30- zinc oxide, octinoxate lotion

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

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Active ingredient:
ZINC OXIDE 10%, OCTINOXATE 7%
Available from:
SALT AND STONE
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
SUNSCREEN - HELPS PREVENT SUNBURN - IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DESCREASES THE RISK OF SKIN CANCER AND EARLY AGING CAUSED BY THE SUN.
Authorization status:
OTC monograph not final
Authorization number:
71585-102-21

PREMIUM SUNSCREEN SPF-30- zinc oxide, octinoxate lotion

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.

----------

MINERAL BASED SALT & STONE PREMIUM SUNSCREEN SPF-30

ACTIVE INGREDIENTS

ZINC OXIDE 10%

OCTINOXATE 7%

PURPOSE

SUNSCREEN

USES

HELPS PREVENT SUNBURN

IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS)

DESCREASES THE RISK OF SKIN CANCER AND EARLY 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 PRODUCT IS SWALLOWED, GET MEDICAL HELP

OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

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

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

* ALOE BARBADENSIS JUICE, * COCOS NUCIFERA (COCONUT) OIL, * HELIANTHUS

ANNUUS (SUNFLOWER) OIL, GLYCERYL STEARATE, * THEOBROMA CACAO (COCOA)

BUTTER, * VITELLARIA PARADOX (SHEA) BUTTER, STEARIC ACID, CETEARYL

ALCOHOL, SODIUM STEARYL LACTATE, * SIMMONDSIA CHINENSIS (JOJOBA) OIL, *

CERA ALBA (BEESWAX), * VANILLA, PHENOXYETHANOL, XANTHAN GUM, *

TOCOPHEROL (VITAMIN E), SODIUM CITRATE, HYDROXYETHYLCELLULOSE, CITRIC

ACID

* CERTIFIED ORGANIC

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

QUESTIONS OR COMMENTS?

CALL TOLL FREE 888 952 4250

PREMIUM SUNSCREEN SPF-30

zinc oxide, octinoxate lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7158 5-10 2

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

10 g in 10 0 mL

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

7 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

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

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

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

CO CO A BUTTER (UNII: 512OYT1CRR)

SHEA BUTTER (UNII: K49 155WL9 Y)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

SO DIUM STEARO YL LACTYLATE (UNII: IN9 9 IT31LN)

JO JO BA O IL (UNII: 724GKU717M)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

VANILLA (UNII: Q74T350 78 H)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

XANTHAN GUM (UNII: TTV12P4NEE)

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

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

HYDRO XYETHYL CELLULO SE ( 10 0 MPA.S AT 2 %) (UNII: R33S7TK2EP)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7158 5-10 2-21

8 8 mL 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

SALT AND STONE

Labeler -

SALT AND ST ONE (080683697)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

JOSHUA TREE PRODUCTS LLC

0 16 171726

ma nufa c ture (7158 5-10 2)

Revised: 4/2019

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