VERSED GUARDS UP DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 35- zinc oxide lotion

Versed Guards Up Daily Mineral Sunscreen Broad Spectrum SPF 35 by

Drug Labeling and Warnings

Versed Guards Up Daily Mineral Sunscreen Broad Spectrum SPF 35 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 15.2%

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.

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating, immediately after toweling drying, and 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, Calcium Sodium Borosilicate, Butyloctyl Salicylate, Isodecyl Neopentanoate, Diheptyl Succinate, C18-21 Alkane, Erythritol, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Capryloyl Glycerin/Sebacic Acid Copolymer, Propanediol, Arachidyl Alcohol, Glycerin, Pyrus Malus (Apple) Fruit Extract, Caprylic/Capric Triglyceride, Tocopherol, Caprylyl Glycol, Coco-Glucoside, Ethyl Ferulate, Behenyl Alcohol, Cetyl Alcohol, Arachidyl Glucoside, Bisabolol, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Xanthan Gum, Octyldodecyl Oleate, Caprylhydroxamic Acid, Hydrolyzed Jojoba Esters, Sodium Hyaluronate, Crithmum, Maritimum Extract, Maltodextrin, Moringa Oleifera Seed Extract, Aloe Barbadensis Leaf, Iron Oxides (CI 77491, CI 77492).

75 mL Tube & Carton

50 mL Tube & Carton

INGREDIENTS AND APPEARANCE

VERSED GUARDS UP DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 35 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73690-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
C18-C21 ALKANE (UNII: 33822S0M40)
ERYTHRITOL (UNII: RA96B954X6)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO GLUCOSIDE (UNII: ICS790225B)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DOCOSANOL (UNII: 9G1OE216XY)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
APPLE (UNII: B423VGH5S9)
XANTHAN GUM (UNII: TTV12P4NEE)
CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEVOMENOL (UNII: 24WE03BX2T)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
SODIUM GLUCONATE (UNII: R6Q3791S76)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
WATER (UNII: 059QF0KO0R)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYL FERULATE (UNII: 5B8915UELW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73690-027-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2021
2	NDC: 73690-027-02	75 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	10/01/2021

Labeler - Offspring Beauty Co. (081516405)