Label: SPORT SUNSCREEN SPF 30 QUALITY CHOICE- avobenzone 2.0% homosalate 10.0% octisalate 5.0% octocrylene 4.0% oxybenzone 5.0% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-778-06 - Packager: Quality Choice
- 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 May 29, 2018
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 2%...........................................Sunscreen
Homosalate 10%.........................................Sunscreen
Octisalate 5%..............................................Sunscreen
Octocrylene 4%..........................................Sunscreen
Oxybenzone 5%..........................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
• apply liberally 15 minutes before sun exposure
• 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 - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPORT SUNSCREEN SPF 30 QUALITY CHOICE
avobenzone 2.0% homosalate 10.0% octisalate 5.0% octocrylene 4.0% oxybenzone 5.0% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-778 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 2 g in 100 mL Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 10 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 4 g in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 5 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Benzyl Alcohol (UNII: LKG8494WBH) Chlorphenesin (UNII: I670DAL4SZ) EDETATE DISODIUM (UNII: 7FLD91C86K) Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X) Oleth-3 (UNII: BQZ26235UC) Propylene Glycol (UNII: 6DC9Q167V3) TOCOPHEROL (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-778-06 473 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/11/2014 Labeler - Quality Choice (011920774) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(63868-778) , label(63868-778)
