ULTRA VIOLETTE FUTURE SCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

Ultra Violette Future Screen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Ultra Violette Future Screen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Grace and Fire USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ZINC OXIDE 20%

PURPOSE

SUNSCREEN

USE

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

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

• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor

Inactive Ingredients

Water, Diisopropyl Adipate, Coco-Caprylate/Caprate, Ethylhexyl Methoxycrylene, C12-15 Alkyl Benzoate, Glyceryl Oleate Citrate, Propanediol, Decyl Glucoside, Polyglyceryl-4 Isostearate, Squalane, Aluminum Starch Octenylsuccinate, Saccharide Isomerate, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Magnesium Aluminum Silicate, Citric Acid, Sodium Citrate, Hydroxyacetophenone, Potassium Cetyl Phosphate, Phenoxyethanol, Polyhydroxystearic Acid, Ammonium Polyacryloyldimethyl Taurate, Lactic Acid, Sodium Hydroxide, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)

Other Information

Protect this product from excessive heat and direct sun

Principal Display Panel

Ultra Violette

Future Screen Broad Spectrum SPF 50

1.7 FL. OZ. (50 mL)

INGREDIENTS AND APPEARANCE

ULTRA VIOLETTE FUTURE SCREEN BROAD SPECTRUM SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84803-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CI 77499 (UNII: XM0M87F357)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SQUALANE (UNII: GW89575KF9)
CI 77492 (UNII: EX438O2MRT)
LACTIC ACID (UNII: 33X04XA5AT)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
WATER (UNII: 059QF0KO0R)
GLYCERYL OLEATE CITRATE (UNII: NLE5KIG74K)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CITRIC ACID (UNII: 2968PHW8QP)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
CI 77491 (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-103-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2024
2	NDC: 84803-103-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2024

Labeler - Grace and Fire USA Inc. (119357605)