SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE- octocrylene, octinoxate, octisalate, oxybenzone, titanium dioxide cream

Sun Protection Creme SPF 30 PLUS by

Drug Labeling and Warnings

Sun Protection Creme SPF 30 PLUS 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 ingredients           Purpose

Octocrylene 5%             Sunscreen

Octinoxate 7.5%            Sunscreen

Octisalate 5%                Sunscreen

Oxybenzone 3%            Sunscreen

Titanium Dioxide 3%      Sunscreen             

PURPOSE

Uses

• Helps Prevent Sunburn

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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

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, not skin cancer or early skin aging.

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

DOSAGE & ADMINISTRATION

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
• At least every 2 hours
• Children under 6 months ask doctor

INACTIVE INGREDIENT

WATER, PROPYLENE GLYCOL, GLYCERIN, GLYCERYL STEARATE, CETYL ALCOHOL, STEARIC ACID, DIMETHICONE, ALOE VERA LEAF, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, POLYSORBATE-20, DMDM HYDANTOIN, METHYLPARABEN, PROPYLPARABEN, IRON OXIDE CI 77491, CI 77492, CI 77499, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SHEA BUTTER, XANTHAN GUM, TOCOPHERYL ACETATE, TRIETHANOLAMINE, FRAGRANCE, BHT

PRINCIPAL DISPLAY PANEL

Exel Clarifying Line

High Sun Protection Creme
SPF 30 PLUS

for use in "Exel Clarifying program"

3.30 fl. oz

INGREDIENTS AND APPEARANCE

SUN PROTECTION CREME SPF 30 PLUS  EXEL CLARIFYING LINE
octocrylene, octinoxate, octisalate, oxybenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53863-122
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 LEAF (UNII: T07U1161SV)
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 COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
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: 53863-122-02	1 in 1 CARTON
1	NDC: 53863-122-01	97.5 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/09/2014

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(53863-122)