Label: GOODSENSE SPF 50 CSPRAY- avobenzone, homosalate, octisalate, octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 70281-634-25 - 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 August 7, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Flammable
- Keep out of reach of children
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Directions
- Hold 4-6 inches from skin and spray over arms, legs, and body in a continuous motion, then quickly rub into skin. Do not spray directly onto face; spray on hands and then apply to face.
- 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
- Questions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
GOODSENSE SPF 50 CSPRAY
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-634 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) LAURYL LACTATE (UNII: G5SU0BFK7O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHENETHYL BENZOATE (UNII: 0C143929GK) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-634-25 155 g in 1 CAN; Type 0: Not a Combination Product 04/23/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/23/2019 Labeler - Solskyn Personal Care LLC (080010329) Establishment Name Address ID/FEI Business Operations KIK Piedmont LLC 078482780 manufacture(70281-634)