PREMIUM SUNSCREEN SPF-30- zinc oxide, octinoxate lotion

PREMIUM SUNSCREEN by

Drug Labeling and Warnings

PREMIUM SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by SALT AND STONE, JOSHUA TREE PRODUCTS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIUM SUNSCREEN  SPF-30
zinc oxide, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
JOJOBA OIL (UNII: 724GKU717M)
YELLOW WAX (UNII: 2ZA36H0S2V)
VANILLA (UNII: Q74T35078H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-102-21	88 mL in 1 TUBE; Type 0: Not a Combination Product	08/29/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/29/2017

Labeler - SALT AND STONE (080683697)

Establishment
Name	Address	ID/FEI	Business Operations
JOSHUA TREE PRODUCTS LLC		016171726	manufacture(71585-102)