Label: CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50- avobenzone, homosalate octisalate, octocrylene cream
- NDC Code(s): 81104-984-11
- Packager: NAKED SUNDAYS PTY LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- USES
-
WARNINGS
Warnings: For external use only. Do not use on
damaged or broken skin. Avoid prolonged sun
exposure. If it gets in your eyes, wash well with
water. Keep out of reach of children. Stop use
and ask a doctor if rashes occur. If product is
swallowed, get medical help or contact a Poison
Control Center right away.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
DIRECTIONS
- SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
- Reapply after 80 minutes of swimming or sweating.
- Reapply immediately after towel drying.
- Reapply at least every 2 hours.
- Children under 3 years of age: Ask a doctor.
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 10.00AM - 2.00PM
- Wear long-sleeved shirts, pants, hats, and sunglasses
- INACTIVE INGREDIENTS
- OTHER INFORMATION
-
USER SAFETY WARNINGS
Directions: Apply generously 15 minutes before
sun exposure. Use a water-resistant sunscreen if
swimming or sweating. Reapply immediately after
towel drying. 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 time in the sun, especially from 10AM - 2PM
Wear long-sleeved shirts, pants, hats, and
sunglasses Children under 6 months of age: Ask a
doctor. - Label
-
INGREDIENTS AND APPEARANCE
CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50
avobenzone, homosalate octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-984 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 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 g Inactive Ingredients Ingredient Name Strength CERESIN (UNII: Q1LS2UJO3A) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) TOMATO JUICE (UNII: U4475AYH9C) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81104-984-11 19 g in 1 CONTAINER; Type 0: Not a Combination Product 06/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/30/2023 Labeler - NAKED SUNDAYS PTY LTD (746918845) Establishment Name Address ID/FEI Business Operations WILD CHILD LABORATORIES PTY LTD 890661643 manufacture(81104-984)
