Label: PROTECT AND PRIME BROAD SPECTRUM SPF30- avobenzone, octinoxate, octocrylene, oxybenzone cream
- NDC Code(s): 70453-001-01
- Packager: Emma Hardie Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Use
- Warnings
-
Directions
- Apply generously 15 minutes before sun exposure
- Use a Water Resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- 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: Sun Protection Measures.
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
-
Inactive ingredients
Water (Aqua), caprylic/capric triglyceride, Green Wattle (Acacia Decurrens)/Jojoba (Simmondsia Chinensis)/Sunflower (Helianthis Annus) Seed Wax/Polyglyceryl-3 Esters, HDI/Trimethylol Hexyllactone Crosspolymer, Tapioca Starch, Manketti (Schinziophyton Rautaneii) Kernel Oil, Shea Butter (Vitellaria Paradoxa), Stearic Acid, Glycerin, Butylene Glycol Stearate SE, Phenoxyethanol, Benzyl Alcohol, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Fragrance (Parfum), Polyhydroxystearic Acid, Geraniol, Limonene, Citronellol, Xanthan Gum, Linalool, Alumina, Aluminum Stearate, Disodium EDTA, Ethylhexylglycerin, Dehydroacetic Acid, Silica, Sodium Stearate, Polymethylsilsesquioxane, Disodium Rutinyl Disulfate, Barley (Hordeum Districhon) Extract, Lemon Balm (Melissa Officinalis) Leaf Extract, Sodium Benzoate, Citral, Citric Acid, Farnesol, Titanium Dioxide (CI 77891)
- Package Labling:
-
INGREDIENTS AND APPEARANCE
PROTECT AND PRIME BROAD SPECTRUM SPF30
avobenzone, octinoxate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70453-001 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E) SHEA BUTTER (UNII: K49155WL9Y) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERIN (UNII: PDC6A3C0OX) 1,4-BUTANEDIOL MONOSTEARATE (UNII: OY671H06VI) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) XANTHAN GUM (UNII: TTV12P4NEE) LINALOOL, (+/-)- (UNII: D81QY6I88E) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM STEARATE (UNII: U6XF9NP8HM) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DEHYDROACETIC ACID (UNII: 2KAG279R6R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STEARATE (UNII: QU7E2XA9TG) DISODIUM RUTINYL DISULFATE (UNII: V5J3537PND) BARLEY (UNII: 5PWM7YLI7R) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRAL (UNII: T7EU0O9VPP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FARNESOL (UNII: EB41QIU6JL) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70453-001-01 1 in 1 BOX 02/03/2016 1 50 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 Drug M020 02/03/2016 Labeler - Emma Hardie Ltd (346913440)
