Active Ingredient
AVOBENZONE G63QQF2NOX 3.0%
OCTISALATE 4X49Y0596W 5.0%
OCTOCRYLENE 5A68WGF6WM 7.0%
HOMOSALATE V06SV4M95S 9%
Sunscreen Glowing, Spf 30 Lotion
FDA Label NDC 70000-0280
10 label sections · Submitted to the FDA by Cardinal Health, Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, Inc for the product Sunscreen Glowing, Spf 30 (NDC 70000-0280). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, warnings, otc - stop use, otc - do not use, otc - keep out of reach of children, indications & usage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Warnings
For external use only Do not use on damaged !i or broken skin.
When using this product keep out of eyes.Rise with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. lf swallowed, get medical help or contact a Poison
ControlCenter right away
Otc - Stop Use
For external use only Do not use on damaged !i or broken skin.
When using this product keep out of eyes.Rise with water to remove.
Stop use and ask a doctor if rash occurs.
Otc - Do Not Use
When using this product keep out of eyes.
Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact a Poison
ControlCenter right away
Indications & Usage
Directions
Apply liberally 15 minutes before sun exposure. Reapply: at least every 2 hours or after
80 minutes of swimming or sweating. Sun Protection Measures: $pending time in the
sun increases your risk of skin cancer andearly skin aging. To decrease this risk,
regularly use a sunscreen with a Broad Spectrum SPfof 15 or higher and other sun
protection measures including: limit time in the sun, especiallyfrom 10 a.m.-2 pm, and
wear long-sleeved shirts, pants, hats, and sunglasses. Childrenunder 6 months of age
ask a doctor.
Dosage & Administration
Apply liberally 15 minutes before sun exposure.
Reapply: at least every 2 hours or after 80 minutes of swimming or sweating.
Otc - When Using
For external use only. Do not use on damagedor broken skin.
When using this product keep out of eyes.nse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. lf swallowed, get medical help or contact a Poison
ControlCenter right away
Inactive Ingredient
WATER
BUTYLOCTYL SALICYLATE
NEOPENTYL GLYCOL DIHEPTANOATE
MICA
CI 77891
BUTYL METHOXYDIBENZOYLMETHANE
GLYCERIN
PROPYLENE GLYCOL
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
CETEARYL ALCOHOL
COCO-GLUCOSIDE
GLYCERYL STEARATE
PEG-100 STEARATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
SILICA
POTASSIUM CETYL PHOSPHATE
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
CETEARYL ALCOHOL
HYDROXYACETOPHENONE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
CI 77492
TRIETHOXYCAPRYLYLSILANE
DISODIUM EDTA
CI 77491
CI 77499
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