FITGLOW VITA SHIELD HYALURONIC PRIMER SPF-30- zinc oxide cream

FITGLOW Vita Shield Hyaluronic Primer SPF-30 by

Drug Labeling and Warnings

FITGLOW Vita Shield Hyaluronic Primer SPF-30 by is a Otc medication manufactured, distributed, or labeled by FITGLOW BEAUTY LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT(S)

Zinc Oxide 14%

PURPOSE

Sunscreen

USE(S)

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• 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 or irritation develops and lasts. 

Keep out of reach of children. 

If swallowed, get medical help or contact a Poison Control Center right away. 

If pregnant or breast-feeding, 

ask a health professional before use.

DIRECTIONS

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
• Limit time in the sun, especially from 10 a.m.-2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information:

• Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Astaxanthin, Benzyl Alcohol, Betula Alba (Birch) Extract, Butyrospermum Parkii (Shea) Butter,C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dehydroacetic Acid, Dodecane, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Lecithin, Mangifera Indica (Mango) Butter, Prunus Domestica (Plum) Fruit Extract, Punica Granatum (Pomegranate) Extract, Rubus Chamaemorus (Cloudberry) Oil, Sodium Polyacrylate, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate, Propanediol.

*Indicates certified organic ingredient.

QUESTIONS?

Distributed by Fitglow Beauty LLC, 700 NE 13 Street, Ft. Lauderdale Florida, 33304 www.fitglowbeauty.com

Package Labeling: 45ml

Package Labeling: 5ml

INGREDIENTS AND APPEARANCE

FITGLOW VITA SHIELD HYALURONIC PRIMER SPF-30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72975-277
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	140 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASTAXANTHIN (UNII: 8XPW32PR7I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SHEA BUTTER (UNII: K49155WL9Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARROT (UNII: L56Z1JK48B)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DODECANE (UNII: 11A386X1QH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYALURONIC ACID (UNII: S270N0TRQY)
MANGO (UNII: I629I3NR86)
PLUM (UNII: 67M3EQ6BE1)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72975-277-00	1 in 1 BOX	02/21/2022
1		45 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 72975-277-01	5 mL in 1 PACKET; Type 0: Not a Combination Product	03/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/21/2022

Labeler - FITGLOW BEAUTY LLC (100394778)