Label: SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTED- zinc oxide spray
- NDC Code(s): 73054-109-06
- Packager: SOLARA SUNCARE, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 29, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
-
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.
Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F.
Stop use and ask a doctor if rash occurs
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- shake well before use
- hold container 4 to 6 inches from the skinapply
- Spray liberally and speard evenly by hand 15 minutes before sun exposure. Do not spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions. Use in a well ventilated area.
- 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 the risk, regularly use asunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially 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
AQUA, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, BUTYLOCTYL SALICYLATE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, BENTONITE, METHYL DIHYDROABIETATE, CETEARYL ALCOHOL, MANGIFERA INDICA (MANGO) FRUIT EXTRACT, ALOE LEAF JUICE, JOJOBA ESTERS, GLYCERIN, BISABOLOL, COCO-GLUCOSIDE, MICROCRYSTALLINE CELLULOSE, CELLULOSE GUM, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, POLYHYDROXYSTEARIC ACID, TOCOPHEROL
- OTHER INFORMATION
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTED
zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73054-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 14 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SAFFLOWER OIL (UNII: 65UEH262IS) BENTONITE (UNII: A3N5ZCN45C) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MANGO (UNII: I629I3NR86) ALOE VERA LEAF (UNII: ZY81Z83H0X) HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) (UNII: AS2SZ9757N) LEVOMENOL (UNII: 24WE03BX2T) COCO GLUCOSIDE (UNII: ICS790225B) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73054-109-06 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/01/2023 Labeler - SOLARA SUNCARE, INC. (040998319)
