Label: EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30- avobenzone, octinoxate, octisalate, oxybenzone lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 42338-001-04 - Packager: Extrashade a Sub of Versitile Group
- 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.
Drug Label Information
Updated November 29, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
-
Directions
• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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 of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses. -
Inactive ingredients
Water (Aqua), Glyceryl Stearate, Ethylhexyl Methoxycrylene, Glycerin, Jojoba Esters, Dimethicone, VP/Eicosene Copolymer, Cetearyl Alcohol, Cetyl Dimethicone, Potassium Cetyl Phosphate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Tocopheryl Acetate, Tertrahexyldecyl Ascorbate, Sodium Hyaluronate, Hydroxyethylcellulose, Hexylene Glycol, Punica Granatum Quillaja (Pomegranate) Extract, Cocos Nucifera (Coconut) Extract, Hedychium Coronarium Root (White Ginger) Extract, Actinidia Chinensis (Kiwi Fruit) Extract, Hibiscus Rosa Sinensis Extract, Passion Flora Incarnata (Passion Flower) Extract, Plantago Major Leaf (Plantain) Extract, Saponaria Bark (Soap Bark) Extract
- Other information
- Questions or comments?
- Purpose
- Description
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- Extra Shade 1
- Extra Shade 2
-
INGREDIENTS AND APPEARANCE
EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30
avobenzone, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42338-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) HEXYLENE GLYCOL (UNII: KEH0A3F75J) COCONUT (UNII: 3RT3536DHY) HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9) KIWI FRUIT (UNII: 71ES77LGJC) HIBISCUS ROSA-SINENSIS FLOWERING TOP (UNII: X9SED65819) PASSIFLORA EDULIS FLOWER (UNII: SY49TH8VUA) PLANTAGO MAJOR LEAF (UNII: 7DC28K241X) SAPONARIA OFFICINALIS ROOT (UNII: RI2K1BMA8B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42338-001-04 1 in 1 CARTON 01/06/2012 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/06/2012 Labeler - Extrashade a Sub of Versitile Group (078350581) Establishment Name Address ID/FEI Business Operations Columbia Cosmetics Manufacturing, Inc. 068267863 manufacture(42338-001)