Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Oxybenzone 3.0% and Padimate O 8.0%
Aruba Aloe Balm NV
TOPICAL
OTC DRUG
Lip Sunscreen and Moisturizer Lip Sunscreen and Moisturizer Helps prevent sunburn
OTC monograph not final
ARUBA ALOE LIP SUNSCREEN AND MOISTURIZER- OXYBENZONE, PADIMATE LIPSTICK ARUBA ALOE BALM NV ---------- ARUBA ALOE LIP SUNSCREEN AND MOISTURIZER Lip Sunscreen and Moisturizer Lip Sunscreen and Moisturizer ACTIVE INGREDIENTS Oxybenzone 3.0% and Padimate O 8.0% USE Helps prevent sunburn WARNINGS Stop use if skin rash occurs INACTIVE INGREDIENTS Petrolatum, Cocoa Butter, Canderila Wax, Beeswax, Coconut Oil, Aruba Aloe Vera Gel, Tocopheryl Acetate (Vitamin E Acetate). DISTRIBUTED IN THE U.S.A. BY ARUBA ALOE OF NORTH AMERICA, LLC, INDIANAPOLIS, IN 46244 MADE IN ARUBA TO REPORT A SERIOUS ADVERSE EVENT CONTACT 1-800-95-ARUBA www.ArubaAloe.com ARUBA ALOE LIP SUNSCREEN AND MOISTURIZER oxybenzone, padimate lipstick PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:53675-140 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 g PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O 8 g in 100 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH PETROLATUM (UNII: 4T6H12BN9U) COCOA BUTTER (UNII: 512OYT1CRR) YELLOW WAX (UNII: 2ZA36H0S2V) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) Aruba Aloe Balm NV ALOE VERA LEAF (UNII: ZY81Z83H0X) ACETATE ION (UNII: 569DQM74SC) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:53675-140- 01 4.8 g in 1 TUBE; Type 0: Not a Combination Product 06/01/2011 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug M020 06/01/2011 LABELER - Aruba Aloe Balm NV (855442273) Revised: 11/2023 Baca dokumen lengkap