Label: GOODSENSE SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70281-601-24 - Packager: Solskyn Personal Care LLC
- 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 June 27, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- 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
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
- DFD
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 10a.m.-2p.m.
- war long-sleeved shirt, pants, hats, and sunglasses
- Children under 6 months: ask a doctor
- Other information
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Inactive ingredients
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
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INGREDIENTS AND APPEARANCE
GOODSENSE SUNSCREEN SPF 30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-601 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g Inactive Ingredients Ingredient Name Strength POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) METHYL GLUCOSE (UNII: QCF122NF3R) STARCH, TAPIOCA (UNII: 24SC3U704I) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PEG-100 STEARATE (UNII: YD01N1999R) PHENETHYL BENZOATE (UNII: 0C143929GK) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-601-24 237 g in 1 CONTAINER; Type 0: Not a Combination Product 01/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/14/2019 Labeler - Solskyn Personal Care LLC (080010329) Establishment Name Address ID/FEI Business Operations Accra Pac, Inc. 024213616 manufacture(70281-601)
