5283 SUNSCREEN- octocrylene, titanium dioxide, octisalate 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

Octocrylene 9%

Titanium dioxide 7%

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 is 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, Isopropyl Myristate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, CETETH-25, Glyceryl Stearate, Glycerin, Dmdm Hydantoin, Methyl Paraben, Propylparaben, Fragrance

Other information

protect this product from excessive heat and direct sun

QUESTIONS

NDC (76138-216-01) DIN 02448890
Made in China for Innovation line.
Los Angeles CA 90066
Questions or Comments?
Call:1-855-755-5346

SPL UNCLASSIFIED SECTION

Broad Spectrum SPF30 Sunscreen Lotion

Packaging

INGREDIENTS AND APPEARANCE

5283 SUNSCREEN 
octocrylene, titanium dioxide, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76138-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-25 (UNII: 5KLY4IOG20)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76138-216-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2018

Labeler - Innovation Specialties (030837314)