Glow Stick Broad Spectrum SPF 50: Package Insert and Label Information

GLOW STICK BROAD SPECTRUM SPF 50- octisalate, octocrylene and avobenzone stick
Taylor James Ltd.

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.

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

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.

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

Supergoop!

Glow Stick Sunscreen

SPF 50

1.23 oz./ 35 g

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front
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GLOW STICK BROAD SPECTRUM SPF 50
avobenzone, octisalate, octocrylene stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-157
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALKYL (C12-15) BENZOATE
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
TAMANU OIL
TOCOPHEROL
MEDIUM-CHAIN TRIGLYCERIDES
SUNFLOWER OIL
ISODODECANE
ISOHEXADECANE
CALENDULA OFFICINALIS FLOWER
MEADOWFOAM SEED OIL
MAURITIA FLEXUOSA FRUIT OIL
OCTYLDODECANOL
DIETHYLHEXYL SYRINGYLIDENEMALONATE
DIBUTYL ETHYLHEXANOYL GLUTAMIDE
DIBUTYL LAUROYL GLUTAMIDE
DICAPRYLYL CARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75936-157-01 35 g in 1 CYLINDER None
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)
Establishment
Name Address ID/FEI Operations
GORDON LABORATORIES,INC 008328619 manufacture (75936-157)

Revised: 01/2020 Taylor James Ltd.

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