SUNSCREEN CREME SPF 37 EXEL- octocrylene,octinoxate,octisalate,oxybenzone,titanium dioxide cream

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Drug Labeling and Warnings

Array by is a Otc medication manufactured, distributed, or labeled by Exelencia Importers Corp, BIOCOSMETICA EXEL ARGENTINA S.R.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Sunscreen Ingredients

Octocrylene (sunscreen) 5,0%

Octinoxate (Ethylhexyl Methoxy cinnamate) (sunscreen) 7,5%

Octisalate (Ethylhexyl Salicylate) (sunscreen) 5,0%

Oxybezone (Benzophenone 3) (sunscreen) 3,0%

Titanium Dioxide (sunscreen) 3,0%

Action:

recommend for use in exfoliating treatments with hydroxy acids during summer and, perticularly, when Exel's "Skin Renewal Micro Peel System" is applied.

Helps prevent sunburn

Ultra moisturizing action. Enhanced with Aloe Vera gel, Shea Butter and Vitamin E Acetate.

Dermatologically tested. It does not contain PABA (4-Aminobenzoic Acid).

Keep out of reach of children.

Stop use if and ask a doctor if rash occurs. If swallowed get medical help or contact a poison control center right away.

External use only.

Do not use in on damaged or broken skin.

Contains Oxybenzone.

When using this product, keep out of eyes.

Skin cancer/ Skin aging alert:

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to prevent sunburn and not skin cancer and early skin aging.

Limit time in the sun 10 am to 2 p (North Hemisphere).

Wear long-sleeve shirts, pants, hats and sunglasses.

Children should avoid prolonged exposure to sunlight.

Sunscreens do not prevent heat stroke.

Product only available through a professional.

How to use

No water resistant product: Apply Liberally 15 minutes before sun exposure.

Reapply at least every two hours. Apply generously before exposure to sun as much as needed. Apply again every 2 hours or immediately after having a bath, energetic activity, excessive perspiration or when using a towel to maintain product effectiveness.

Children under 6 months: ask a doctor.

Protect this product from excessive heat and sunlight.

INCI Inactive Ingredients

Deionized Water (aqua) * Propylene Glycol * Glycerin * Glyceryl Stearate * Cetyl Alcohol * Stearic Acid * Dimethicone * Aloe Barbadensis (Leaf Extract) * Hamamelis Liquid Extract (Hamamelis Virginiana Extract) * Polysorbate 20 * DMDM Hydantoin
* Methylparaben * propylparaben * Iron Oxides (CI:77.491, CI:77.492, CI 77.499) * Acrylates/C10-30 Alkyl Acrylate Crosspolymer * Shea butter (Butyrospermum Parkii Butter) * Xanthan Gum * Tocopheryl Acetate (vitamin E acetate) * Triethanolamine
* Fragrance (Parfum) * BHT.

PRINCIPAL DISPLAY PANEL

Exel

Sun Protection Creme SPF

contains Vitamin E Acetate, Shea Butter, and Aloe Vera Gel.

1.69 fl. oz 50

INGREDIENTS AND APPEARANCE

SUNSCREEN CREME SPF 37  EXEL
octocrylene,octinoxate,octisalate,oxybenzone,titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53863-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SHEA BUTTER (UNII: K49155WL9Y)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53863-120-02	1 in 1 CARTON
1	NDC: 53863-120-01	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/15/2012

Labeler - Exelencia Importers Corp (147644335)

Registrant - Exelencia Importers Corp (147644335)

Establishment
Name	Address	ID/FEI	Business Operations
BIOCOSMETICA EXEL ARGENTINA S.R.L.		971813332	manufacture(53863-120)