VERSED SPF 30 REPLENISHING BODY MINERAL- zinc oxide lotion

Versed SPF 30 Replenishing Body Mineral by

Drug Labeling and Warnings

Versed SPF 30 Replenishing Body Mineral by is a Otc medication manufactured, distributed, or labeled by Offspring Beauty Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide - 17.6%

Purpose

Sunscreen

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

Directions

• Shake well, apply liberally and evenly 15 minutes before sun exposure
• Reapply after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.
• Children under 6 months of age: ask a doctor
• 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 sunscreen with a Broad Spectrum SPF value of 15 or higher and othe sun protection measures including: limit time in sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses

Other information

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

INACTIVE INGREDIENT

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Vitis Vinifera (Grape) Seed Oil, Methyl Dihydroabietate, Propanediol, Potassium Cetyl Phosphate, Diheptyl Succinate, Arachidyl Alcohol, Cetyl Alcohol, Tetradecane, Sodium Stearoyl Glutamate, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Behenyl Alcohol, Sodium PCA, Theobroma Grandiflorum Seed Butter, Arachidyl Glucoside, Xanthan Gum, Sodium Gluconate, Bisabolol, Citric Acid, Caprylhydroxamic Acid, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Glycerin, Camellia Sinensis Leaf Extract, Tocopherol, Sodium Benzoate, Potassium Sorbate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VERSED SPF 30 REPLENISHING BODY MINERAL 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73690-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TETRADECANE (UNII: 03LY784Y58)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GRAPE SEED OIL (UNII: 930MLC8XGG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DOCOSANOL (UNII: 9G1OE216XY)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
WATER (UNII: 059QF0KO0R)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73690-028-01	177 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	05/01/2023

Labeler - Offspring Beauty Co. (081516405)