![VITAMIN C GLOW-PROTECT SPF 30 (OCTISALATE, AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) LOTION [BUTH-NA-BODHAIGE, INC.,]](https://medic.hrt.org//dailymed/images/639fdca0-8c0b-45ee-8302-506efb19357c/vitamin-01.jpg)
| NDC | 57691-977-50 |
| Set ID | 639fdca0-8c0b-45ee-8302-506efb19357c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Buth-Na-Bodhaige, Inc., |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
-
Directions
- Apply liberally 15 minutes before sun exposure.
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in sun especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- reapply this product at least every 2 hours.
- use water resistant sunscreen if swimming or sweating.
- children under 6 months of age: ask a doctor.
- Other information
-
Inactive Ingredients
Water, Isododecane, Hydrogenated Polydecene, Glycerin, Glyceryl Stearate, Arachidyl Alcohol, Caprylyl Glycol, Behenyl Alcohol, PEG-100 Stearate, Arachidyl Glucoside, Cetyl Alcohol, Sesamum Indicum (Sesame) Seed Oil, Tetrahexyldecyl Ascorbate, Phenoxyethanol, Acrylamide/Ammonium Acrylate Copolymer, Fragrance, Xanthan Gum, Polyisobutene, Dimethicone, Myrciaria Dubia Fruit Extract, Sorbic Acid, Disodium EDTA, Linalool, Limonene, Polysorbate 20, Sorbitan Isostearate, Benzyl Benzoate, Citral, Potassium Sorbate, Hexyl Cinnamal, Citronellol.
- PRINCIPAL DISPLAY PANEL - 50 ml Tube Label
-
INGREDIENTS AND APPEARANCE
VITAMIN C GLOW-PROTECT SPF 30
octisalate, avobenzone, octinoxate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57691-977 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.02 g in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Isododecane (UNII: A8289P68Y2) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) Glycerin (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Arachidyl Alcohol (UNII: 1QR1QRA9BU) Caprylyl Glycol (UNII: 00YIU5438U) DOCOSANOL (UNII: 9G1OE216XY) PEG-100 Stearate (UNII: YD01N1999R) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Cetyl Alcohol (UNII: 936JST6JCN) SESAME OIL (UNII: QX10HYY4QV) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) Phenoxyethanol (UNII: HIE492ZZ3T) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Xanthan Gum (UNII: TTV12P4NEE) POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K) Dimethicone (UNII: 92RU3N3Y1O) MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP) Sorbic Acid (UNII: X045WJ989B) EDETATE DISODIUM (UNII: 7FLD91C86K) Polysorbate 20 (UNII: 7T1F30V5YH) Sorbitan Isostearate (UNII: 01S2G2C1E4) Potassium Sorbate (UNII: 1VPU26JZZ4) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57691-977-50 50 mL in 1 TUBE; Type 0: Not a Combination Product 10/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 10/31/2020 Labeler - Buth-Na-Bodhaige, Inc., (791071279)
