5414 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate lotion

5414 Sunscreen by

Drug Labeling and Warnings

5414 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Innovation Specialties. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient:

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

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

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

Directions

apply liberally 15 minutes before sun exposure.
reapply:

• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

Sun Protection Measure.

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 of 15 higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Other information

• protect this product from excessive heat and direct sun

Questions?

HOTLINE # 1-855-755 5346
NPN# 80062390

SPL UNCLASSIFIED SECTION

1FL OZ (30ML)
Made in China For Innovation Line Los Angeles,
CA 90066
Product # 5414

Packaging

INGREDIENTS AND APPEARANCE

5414 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76138-218
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
LEVOMENOL (UNII: 24WE03BX2T)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76138-218-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/20/2018

Labeler - Innovation Specialties (030837314)