Otc - Active Ingredient
Homosalate 15%, Octocrylene 10%, Octisalate 5%, Avobenzone 3%
Poolside Orange Creme Spf 30 Sunscreen Oil Mist Spray
FDA Label NDC 85161-144
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Longway Technology(guangzhou)co.,ltd. for the product Poolside Orange Creme Spf 30 Sunscreen Oil Mist (NDC 85161-144). 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 otc - active ingredient, otc - questions, otc - keep out of reach of children, otc - purpose, other safety information, inactive ingredient, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Questions
1-212-244-5170 l [email protected]
Otc - Keep Out Of Reach Of Children
If product is swallowed get medical help or contact a poison control center right away.
Otc - Purpose
Sunscreen
Other Safety Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
CAPRYLIC/CAPRIC TRIGLYCERIDE, ALCOHOL DENAT., BUTYLOCTYL SALICYLATE, FRAGRANCE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL
Warnings
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 sunbur, 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 doctor if rash occurs.
Keep out of reach of chlldren. If product is swallowed get medical help or contact a poison control center right away.
Dosage & Administration
Directions .
Apply generously and evenly 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Chlldren under 6 month: ask a doctor.
Indications & Usage
For external use only.
Package Label.Principal Display Panel
Poolside Orange Creme Spf 30 Sunscreen Oil Mist (06)
* Please review the disclaimer below.
