Label: GLOSSIER SUN GLAZE GLEAMING SUNSCREEN OIL BROAD SPECTRUM SPF 30 WATER RESISTANT 40 MIN aerosol, spray
- NDC Code(s): 71425-030-06
- Packager: Glossier Inc.
- 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 November 13, 2018
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- Official Label (Printer Friendly)
- Active Ingredients
- Uses
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Warnings
For external use only
Flammable: Contents under pressure. Do not puncture or incinerate.
Do not store at temperature above 120°F. Use only as directed. Intentional
misuse by deliberately con-centrating and inhaling the contents can be
harmful or fatal. Keep out of reach of children.
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away. -
Directions
• apply generously 15 minutes before sun exposure
• reapply: •after 40 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
value 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor -
Inactive ingredients
Alcohol Denat., Isobutane, Butyloctyl Salicylate, Diethylhexyl 2,6-Naphthalate, Caprylyl Methicone, Parfum/Fragrance, Acrylates/Octylacrylamide Copolymer, Mica, Dibutyl Adipate, Tocopheryl Acetate, Ascorbyl Palmitate, Mauritia Flexuosa Fruit Oil, Prunus Armeniaca (Apricot) Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Mimosa Tenuiflora Bark Extract, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides).
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INGREDIENTS AND APPEARANCE
GLOSSIER SUN GLAZE GLEAMING SUNSCREEN OIL BROAD SPECTRUM SPF 30 WATER RESISTANT 40 MIN
glossier sun glaze gleaming sunscreen oil broad spectrum spf 30 water resistant 40 min aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71425-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ISOBUTANE (UNII: BXR49TP611) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) MICA (UNII: V8A1AW0880) DIBUTYL ADIPATE (UNII: F4K100DXP3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) PRUNUS ARMENIACA SEED (UNII: 75356789IW) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) MIMOSA TENUIFLORA BARK (UNII: 515MQE449I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BROWN IRON OXIDE (UNII: 1N032N7MFO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71425-030-06 1 in 1 PACKAGE 01/01/2019 1 167 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/01/2019 Labeler - Glossier Inc. (078541007)
