Poolside Sun Daze Body Illuminator Spf 30 Shimmer Sunscreen Gel
FDA Label NDC 85179-042
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by I World Llc for the product Poolside Sun Daze Body Illuminator Spf 30 Shimmer Sunscreen (NDC 85179-042). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Homosalate 10%, Octocrylene 6%, Octisalate 5%, Avobenzone 3%
Purpose
Sunscreen
Uses
- Helps prevent sunburn.
Warnings
For external use only.
Skin cancer/skin aging alert
- Spending time in the sun increases your risk of skin cancer and early skin aging.
- This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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 Doctor If
- rash occurs.
Keep Out Of Reach Of Children.
- If product is swallowed get medical help or contact a poison control centre right away.
Directions
- Apply generously and evenly 15 minutes before sun exposer.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 month: ask a doctor.
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
MINERAL OIL (PARAFFINUM LIQUIDUM), HYDROGENATED STYRENE/ISOPRENE COPOLYMER, SILICA DIMETHYL SILYLATE, GLYCERYL CAPRYLATE, FRAGRANCE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SQUALANE, MACADAMIA INTEGRIFOLIA SEED OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, SYNTHETIC FLUORPHLOGOPITE, MICA, TIN OXIDE, IRON OXIDES (CI 77491), TITANIUM DIOXIDE (CI 77891), FD&C YELLOW NO. 5 (CI 19140), FD&C RED NO. 40 (CI 16035).
Questions Or Comments?
1-212-244-5170 [email protected]
Package Labeling:
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