SUNSCREEN- homosalate, octinoxate, zinc oxide lotion

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by Imperfect Foods. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 15%

Octisalate 5%

Zinc Oxide 4%

PURPOSE

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

Ask a doctor

Stop use and ask a doctor if rash develops

When Using

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children

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

Directions

• Apply liberally 15 minutes before sun exposure
• reapply: use a water resistant sunscreen if swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months: ask a doctor

Other Information

• Protect this product from excessive heat and direct sun
• may stain some fabrics

Inactive Ingredients

Water (Aqua), Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, Cetearyl Alcohol, Phenoxyethanol, C13-14 Isoparaffin, Caprylyl Glycol, Cyclotetrasiloxane, Lauroyl Lysine, Ethylhexylglycerin, Polyhydroxystearic Acid, Hexylene Glycol, Laureth-7, Allantoin, Dimethiconde/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Triethoxycaprylylsilane.

Questions or Comments?

1-833-906-2662 Monday - Friday 9AM-5PM MST

PRINCIPAL DISPLAY PANEL

SPF 15 Face Lotion NDC: 81757-001-04

INGREDIENTS AND APPEARANCE

SUNSCREEN 
homosalate, octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81757-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
OCTAMETHYLTETRASILOXANE (UNII: YB15PH50RH)
LAURETH-7 (UNII: Z95S6G8201)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALLANTOIN (UNII: 344S277G0Z)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG-100 STEARATE (UNII: YD01N1999R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
LAUROYL LYSINE (UNII: 113171Q70B)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81757-001-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	04/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/13/2021

Labeler - Imperfect Foods (109460818)