SOLARA SUNCARE - GO VACATION GLOW SPF 30- zinc oxide lotion

SOLARA SUNCARE - GO VACATION GLOW by

Drug Labeling and Warnings

SOLARA SUNCARE - GO VACATION GLOW by is a Otc medication manufactured, distributed, or labeled by SOLARA SUNCARE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 18.9%

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.

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 before each use
• apply generously and evenly 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every two 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

Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Coco-Glucoside, Euterpe Oleracea (Acai) Fruit Extract, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Sprout Extract, Hydrolyzed Jojoba Esters, Butyrospermum Parkii Nut Extract, Caesalpinea Spinosa Fruit Pod Extract, Caprylhydroxamic Acid, Glyceryl Caprylate, Cetearyl Glucoside, Caprylyl/Capric Glucoside, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Dipotassium Glycyrrhizinate, Sodium Phytate, Propylene Glycol, Xanthan Gum, Sclerotium Gum, Phenoxyethanol, Sodium Benzoate, Tocopherol, Octyldodecanol, Sorbitan Oleate, Alumina, Magnesium Oxide, May Contain +/- : CI 77491, CI 77492, CI 77499 (Iron Oxides), Mica

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 VACATION GLOW  SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73054-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT ALKANES (UNII: 1E5KJY107T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO GLUCOSIDE (UNII: ICS790225B)
ACAI (UNII: 46AM2VJ0AW)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
SHEA BUTTER (UNII: K49155WL9Y)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
TRIPOTASSIUM GLYCYRRHIZINATE (UNII: LD4YKZ48B6)
PHYTATE SODIUM (UNII: 88496G1ERL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
OCTYLDODECANOL (UNII: 461N1O614Y)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73054-127-11	1 in 1 BOX	10/17/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/17/2021

Labeler - SOLARA SUNCARE, INC. (040998319)