LIGHTENING HIGH SUN PROTECTION CREAM- octocrylene, titanium dioxide, avobenzone cream

Lightening High Sun Protection Cream by

Drug Labeling and Warnings

Lightening High Sun Protection Cream by is a Otc medication manufactured, distributed, or labeled by Casmara Cosmetics, SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS PURPOSE

Octocrylene 10%.................... Sunscreen

Titanium Dioxide 5.1%............ Sunscreen

Avobenzone 4%..................... Sunscreen

Warnings

SUN ALERT: The sun causes skin damages. Regular use of sunscreens over the years may reduce the risks of skin damages, some types of skin cancer, and other harmful effects due to the sun

For external use only, not to be swallowed.

Do not use on damaged or broken skin.

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

DIscontinue uses if signs or irritationsor rash appears. If irritation or rash persists, consult with a doctor.

Keep out of reach of children.

Children under 6 months: as a doctor.

WARNINGS

Stop use and ask a doctor if rash occurs

Children under 6 months: ask a doctor

Warnings

Keep out of reach of children

Questions or comments?

+ 34 961 501 999 M-F 9:00 am to 5:00 pm

Other Information

. keep the product in a cool and dry place

Directions

• adults and childrens 6 months of age and over: apply generaously before sun exposure. Reapply after swiming, excessive sweating or anytime after towel drying. Children under 2 years of age or less should use sunscreen products with a minium of SPF 4
• children under 6 months of age, consult with a doctor

• adults and childrens 6 months of age and over: apply generaously before sun exposure. Reapply after swiming, excessive sweating or anytime after towel drying. Children under 2 years of age or less should use sunscreen products with a minium of SPF 4
• children under 6 months of age, consult with a doctor

Uses

• provides high protection against sunburns
• sunscreen to help prevent sunburns. FIlters the sun rays to help prevent the skin damages

Inactive Ingredients

Water, Glycerin, Butylene glycol dicaprylate/dicaprate, Ethylhexyl salicylate, Alcohol denat, Bemotrizinol, Polysilicone-15, Cetyl alcohol, Glyceryl stearate, Phenoxyethanol, PEG-75 stearate, Silica, Xanthan gum, Butylene glycol, Ceteth-20, Steareth-20, Dimethicone, Ethylhexylglycerin, Tetrasodium glutamate diacetate, Fragrance, Soybean protein

Uses

• provides high protection against sunburns
• sunscreen to help prevent sunburns. FIlters the sun rays to help prevent the skin damages

Package Label

INGREDIENTS AND APPEARANCE

LIGHTENING HIGH SUN PROTECTION CREAM 
octocrylene, titanium dioxide, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20151-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.1 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	4 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)	0.12 mg  in 1 mL
SOYBEAN (UNII: L7HT8F1ZOD)	0.02 mg  in 1 mL
CETETH-20 (UNII: I835H2IHHX)	0.372 mg  in 1 mL
STEARETH-20 (UNII: L0Q8IK9E08)	0.372 mg  in 1 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	0.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W)	5 mg  in 1 mL
POLYSILICONE-15 (UNII: F8DRP5BB29)	3 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.1 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	43.56 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M)	4.8 mg  in 1 mL
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)	5 mg  in 1 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	0.094 mg  in 1 mL
BEMOTRIZINOL (UNII: PWZ1720CBH)	4 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	7 mg  in 1 mL
CETYL ALCOHOL (UNII: 936JST6JCN)	1.87 mg  in 1 mL
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)	1.875 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.9 mg  in 1 mL
PEG-75 STEARATE (UNII: OT38R0N74H)	0.872 mg  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	0.78 mg  in 1 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.6 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20151-105-02	1 in 1 BOTTLE, DISPENSING	04/01/2017
1	NDC: 20151-105-01	50 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/29/2017

Labeler - Casmara Cosmetics, SA (464973544)

Registrant - Casmara Cosmetics, SA (464973544)

Establishment
Name	Address	ID/FEI	Business Operations
Casmara Cosmetics, SA		464973544	manufacture(20151-105)