![SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP]](https://medic.hrt.org//dailymed/images/bfcf87c0-27c4-4fba-9f4e-77e7132e073a/bottle.jpg)
![SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP]](https://medic.hrt.org//dailymed/images/bfcf87c0-27c4-4fba-9f4e-77e7132e073a/carton.jpg)
| NDC | 53863-120-01, 53863-120-02 |
| Set ID | bfcf87c0-27c4-4fba-9f4e-77e7132e073a |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Exelencia Importers Corp |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
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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
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INGREDIENTS AND APPEARANCE
SUNSCREEN CREME SPF 37 EXEL
octocrylene,octinoxate,octisalate,oxybenzone,titanium dioxide creamProduct 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)
