Active Ingredients
Octyl Methoxy Cinnamate 7.00% Sunscreen
Titanium Dioxide 1.25% Sunscreen
Zinc Oxide 1.25% Sunscreen
Octyl Salicylate 1.00% Sunscreen
Sunstation Usa Spf-30 Sport Sunscreen Lotion
FDA Label NDC 76348-407
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Sunstation Usa Spf-30 Sport Sunscreen (NDC 76348-407). 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 ingredients, purpose, uses, warnings, directions, other ingredients, recent major changes, statement of identity, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Octyl Methoxy Cinnamate 7.00% Sunscreen
Titanium Dioxide 1.25% Sunscreen
Zinc Oxide 1.25% Sunscreen
Octyl Salicylate 1.00% Sunscreen
Uses
- Helps prevent sunburn.
- higher SPF gives more sunburn protection
- retains SPF after 80 minutes of swimming or sweating
- If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.
Warnings
- For external use only.
- 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 or irritation develops and lasts
- Keep out of reach of children.
- If swallowed, get medical help, or contact a Poison Control Center right away.
- If pregnant or breast-feeding, ask a health professional before use.
Directions
- Apply liberally 15 minutes before sun exposure and as needed.
- Children under 6 months of age: ask a doctor.
- After 80 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially between 10am and 2pm.
- Wear long sleeve shirts, pants, hats and sunglasses.
Other Ingredients
Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Deionized Water, Dimethicone, Glycerin, Hexylene Glycol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol, Polyester-7, Neopentyl Glycol, Diheptanoate, Sorbitol, Stearic Acid,
Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine, Tocopheryl Acetate (Vitamin E)
Recent Major Changes
- added more descriptive text. No major change.
- Changes to Directions are not major - just a reordering of phrases.
Statement Of Identity
SUNSTATION USA®
SPF-30 SPORT SUNSCREEN
OXYBENZONE & PARABEN FREE
UVA/UVB PROTECTION SUNSCREEN
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help, or contact a Poison Control Center right away.
Other Safety Information
Protect the product in this container from excessive heat and direct sun
Otc - Questions
QUESTIONS ?
816-686-1345
Sunstation Product Label
Sunstation Label (Thumbnail)
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