SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTED- zinc oxide spray

SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST by

Drug Labeling and Warnings

SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST by is a Otc medication manufactured, distributed, or labeled by SOLARA SUNCARE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Non-Nano, Non-Coated Zinc Oxide 14%

PURPOSE

Sunscreen

USES

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin 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.

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

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

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

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

• Protect this product from excessive heat and direct sun.

QUESTIONS OR COMMENTS

• 1-855-859-1600 (9am – 5pm ET)

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 spray

Product 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)