Label: SOL-OR BROAD SPECTRUM SPF- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 13630-0284-4
- Packager: Prime Packaging, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 17, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only.
When using this product
- keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure- do not puncture or incinerate.
Do not store at temoeratures above 120°F.
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Directions
- Spray liberally and spread evenly by hand 15 minutes before sun exposure, hold container 4 to 6 inches from the skin to apply, do not spray directly into face. Spray on hands then apply to face, do not apply in windy conditions, use in a well-ventilated area.
- Reapply:
- 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 a 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-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor
- Inactive Ingredients
- Other Information
- Question or comments?
- NO-AD Sunscreen Broad Spectrum SPF 50 Continuous Spray
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INGREDIENTS AND APPEARANCE
SOL-OR BROAD SPECTRUM SPF
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0284 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 126.75 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 23.24 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 42.25 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25.35 mg in 1 g Inactive Ingredients Ingredient Name Strength DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) ALOE VERA LEAF (UNII: ZY81Z83H0X) MINERAL OIL (UNII: T5L8T28FGP) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) COCONUT OIL (UNII: Q9L0O73W7L) ISOPROPYL ALCOHOL (UNII: ND2M416302) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color yellow (Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0284-4 149 g in 1 CAN; Type 0: Not a Combination Product 09/20/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/20/2022 Labeler - Prime Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0284) , label(13630-0284) , analysis(13630-0284) , pack(13630-0284) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0284) , pack(13630-0284)
