Label: GOODSENSE SUNSCREEN SPF 70- avebenzone, homosalate, octisalate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70281-661-24 - 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 July 24, 2019
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- 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 high and other sun protection measures including:
- Limit time in the sun, especially from 10a.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, Polyglyceryl -3 Methylglucose Distearate, Tapioca Starch, Glyceryl Stearate, PEG-I00 Stearate, Phenethyl Benzoate, Microcrystalline Cellulose, Cellulose Gum, Tocopheryl Acetate, Fragrance, Stearic Acid, 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 70
avebenzone, homosalate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-661 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) UNDECYLENIC ACID (UNII: K3D86KJ24N) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) STARCH, TAPIOCA (UNII: 24SC3U704I) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) PHENETHYL BENZOATE (UNII: 0C143929GK) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) STEARIC ACID (UNII: 4ELV7Z65AP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-661-24 237 g in 1 CONTAINER; Type 0: Not a Combination Product 03/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/22/2019 Labeler - Solskyn Personal Care LLC (080010329) Establishment Name Address ID/FEI Business Operations Accra Pac, Inc. 024213616 manufacture(70281-661)
