Label: ALBA SUNBLOCK NATURAL LAVENDER SPF 45 - homosalate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicilate, titanium dioxide cream
- NDC Code(s): 61995-2393-4
- Packager: The Hain Celestial Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 6, 2010
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
Ethylhexyl Methoxycinnamate 7.5%
Ethylhexyl Salicilate 5.0%Titanium Dioxide 2.0% Close
- INDICATIONS & USAGE
- Helps prevent sunburns
- Higher SPF gives more sunburn protection
- Apply liberally as needed 15 to 20 minutes before sun exposure
- Reapply as needed or after swimming, perspiring or towel drying
- Children under 6 months of age: ask doctor
WARNINGSFor external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact Poison Center right away. Close
Call (888) 659-7730 or visit www.AlbaBotanica.com
100% Vegetarian Ingredients
No Animal Testing
The Hain Celestial Group, Inc.
Melville, NY 11747Made in the U.S.A. Close
- INGREDIENTS AND APPEARANCE
ALBA SUNBLOCK NATURAL LAVENDER SPF 45
homosalate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicilate, titanium dioxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2393 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 10 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 10 g in 100 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 5.0 g in 100 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 2.0 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2393-4 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/28/2009 Labeler - The Hain Celestial Group, Inc. (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 858894996 manufacture