5283 SUNSCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide lotion

5283 sunscreen by

Drug Labeling and Warnings

5283 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

Octinoxate          7.5%

Octisalate           2.0%

Oxybenzone       4.0%

Titanium dioxide  2.5%

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, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Glycerin, Glyceryl Stearate, Myristyl Propionate, Propylene Glycol Dioleate, Ceteareth-25, PEG-9 Dimethicone, Xanthan Gum, Disodium EDTA, Fragrance.

​Other information

protect this product from excessive heat and direct sun

QUESTIONS

 DIN 02448890

Questions or Comments? Made in China

for Innovation line. Los Angeles CA 90066

Questions ? Call: 1-855-755-5346​​​​           

SPL UNCLASSIFIED SECTION

Broad Spectrum SPF30 Lotion

Packaging

INGREDIENTS AND APPEARANCE

5283 SUNSCREEN 
octinoxate, octisalate, oxybenzone, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76138-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MYRISTYL PROPIONATE (UNII: P59053E7NJ)
PROPYLENE GLYCOL DIOLEATE (UNII: 84T0LSN7U6)
CETEARETH-25 (UNII: 8FA93U5T67)
PEG-9 DIMETHICONE (400 CST) (UNII: 9OZ27X065D)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Product Characteristics
Color		Score
Shape		Size
Flavor	COCONUT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76138-205-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/15/2017

Labeler - Innovation Specialties (030837314)