Label: PREMIUM SUNSCREEN SPF-30- zinc oxide, octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71585-102-21 - Packager: SALT AND STONE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 11, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
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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
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREMIUM SUNSCREEN SPF-30
zinc oxide, octinoxate lotionProduct 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)
