Label: GOODSENSE SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70281-639-24 - Packager: Solskyn Personal Care LLC
- Category: HUMAN OTC DRUG LABEL
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 June 27, 2019
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
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Directions
• Apply liberally 15 minutes before sun exposure
• Re-apply: ■ 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 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-sleeved shirts, pants, hats and sunglasses
• Children under 6 months: ask a doctor
- Other information
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Inactive Ingredients:
Water, Glycerin, C28-52 Olefin/Undecylenic Acid Copolymer, Neopentyl Glycol Diheptanoate, Stearic Acid, Polyglyceryl-3 Methylglucose Distearate, Tapioca Starch, Glyceryl Stearate, PEG-100 Stearate, Microcrystalline Cellulose, Phenethyl Benzoate, Cellulose Gum, Tocopheryl Acetate, Fragrance, Polymethylsilsesquioxane, Caprylyl Glycol, Aloe Barbadensis Leaf Juice, Stearyl Alcohol, Dimethicone, Disodium EDTA, Sodium Hydroxide, Phenoxyethanol
- Questions
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INGREDIENTS AND APPEARANCE
GOODSENSE SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-639 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 13 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 g Inactive Ingredients Ingredient Name Strength STARCH, TAPIOCA (UNII: 24SC3U704I) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHENETHYL BENZOATE (UNII: 0C143929GK) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALOE VERA LEAF (UNII: ZY81Z83H0X) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) UNDECYLENIC ACID (UNII: K3D86KJ24N) NEOPENTYL GLYCOL (UNII: QI80HXD6S5) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-639-24 237 g in 1 CONTAINER; Type 0: Not a Combination Product 04/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/02/2019 Labeler - Solskyn Personal Care LLC (080010329) Establishment Name Address ID/FEI Business Operations Accra Pac, Inc. 024213616 manufacture(70281-639)
