Label: GLOW STICK BROAD SPECTRUM SPF 50- avobenzone, octisalate, octocrylene stick
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-157-01 - Packager: Taylor James Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 October 27, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Apply generously and evenly 15 minutes before sun exposure
- Use a water-resistant sunscreen if swimming or sweating
- Reapply 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 value of 15 or higher and other sun
protection measures including:• limit your time in the sun, especially from 10
a.m. – 2 p.m.• wear long-sleeved shirts, pants, hats, and sunglasses
•Children under 6 months of age: ask a doctor.
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INACTIVE INGREDIENT
Inactive ingredients
C12-15 Alkyl Benzoate, Calendula Officinalis Extract, Calophyllum Inophyllum Seed Oil, Caprylic/Capric Triglyceride, Dibutyl Ethylhexanol Glutamide, Dibutyl Lauroyl Glutamide, Dicaprylyl Carbonate, Diethylhexyl Syringylidenemalonate, Helianthus Annuus (Sunflower) Oil, Isododecane, Isohexadecane, Limnanthes Alba (Meadowfoam) Seed Oil, Maurita Flexuosa Fruit Oil, Octyldodecanol, Pentaclethra, Macroloba Oil, Polyester-8, Tocopherol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GLOW STICK BROAD SPECTRUM SPF 50
avobenzone, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-157 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) OCTYLDODECANOL (UNII: 461N1O614Y) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS) DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) TAMANU OIL (UNII: JT3LVK84A1) TOCOPHEROL (UNII: R0ZB2556P8) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SUNFLOWER OIL (UNII: 3W1JG795YI) ISODODECANE (UNII: A8289P68Y2) ISOHEXADECANE (UNII: 918X1OUF1E) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-157-01 35 g in 1 CYLINDER; Type 0: Not a Combination Product 12/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/20/2019 Labeler - Taylor James Ltd. (033381850)
