Version
v1
SUN BUFF SPF 30 MINERAL SUNSCREEN — v1
SUN BUFF SPF 30 MINERAL SUNSCREEN
12 Views
Effective date
September 24, 2025
Original packager
Yes
Sections captured
13
Identifiers
- Document ID
- 3f874062-ebac-8993-e063-6294a90abfc5
- Set ID
- 3f874062-ebab-8993-e063-6294a90abfc5
- Application numbers
- M020
- Product NDCs
- 58274-030
- Package NDCs
- 58274-030-01
- Original packager NDCs
- —
Names & Manufacturers
- Brand names
- SUN BUFF SPF 30 MINERAL SUNSCREEN
- Generic names
- ZINC OXIDE/TITANIUM DIOXIDE
- Manufacturer names
- SPF Ventures, LLC
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- TITANIUM DIOXIDE, ZINC OXIDE
- Routes
- TOPICAL
- Pharmacologic class (PE)
- —
- Pharmacologic class (EPC)
- —
- Pharmacologic class (CS)
- —
- Mechanism of action
- —
Other identifiers
- NUI
- —
- RxCUI
- —
- UNII
- 15FIX9V2JP, SOI2LOH54Z
- UPC
- —
Structured Label Sections
Active Ingredient (1)
Sequence 1
Active ingredients ZINC OXIDE 14.1% TITANIUM DIOXIDE 8.05%
Do Not Use (1)
Sequence 1
Do not use Do not use on damaged or broken skin.
Dosage And Administration (1)
Sequence 1
Directions Apply liberally 15 minutes before sub exposure and as needed Reapply: After 80 minutes of swimming or sweating; Immediately after towel drying; At least every 2 hours Sub 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
Inactive Ingredient (1)
Sequence 1
Inactive ingredients MICA SILICA BORON NITRIDE DIMETHYLIMIDAZOLIDINONE RICE STARCH IRON OXIDES (CI 77492) LAUROYL LYSINE SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL TRIETHOXYCAPRYLYLSILANE TITANIUM DIOXIDE (CI 77981) GLYCERYL CAPRYLATE IRON OXIDES (CI 77491) ETHYL FERULATE CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL BISABOLOL IRON OXIDES (CI 77499) ORYZA SATIVA (RICE) LIPIDS GLYCERIN CAPRYLHYDROXAMIC ACID CAMELLIA SINENSIS EXTRACT CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT
Indications And Usage (1)
Sequence 1
Uses Helps prevent sunburn If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Keep Out Of Reach Of Children (1)
Sequence 1
Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)
Sequence 1
Label label
Purpose (1)
Sequence 1
Purpose Sunscreen
Spl Product Data Elements (1)
Sequence 1
SUN BUFF SPF 30 MINERAL SUNSCREEN ZINC OXIDE/TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE BORON NITRIDE CHAMOMILE CAMELLIA SINENSIS LEAF SILICA CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL BISABOLOL GLYCERIN LAUROYL LYSINE CI 77499 GLYCERYL CAPRYLATE ETHYL FERULATE ZINC OXIDE ZINC OXIDE DIMETHYLIMIDAZOLIDINONE RICE STARCH CI 77492 RICE BRAN OIL SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL MICA CI 77491 TRIETHOXYCAPRYLYLSILANE CAPRYLHYDROXAMIC ACID
Stop Use (1)
Sequence 1
Stop use and ask a doctor Stop use and ask a doctor if rash or irritation develops and lasts.
Storage And Handling (1)
Sequence 1
Other Information Protect the product in this container from excessive heat and direct sun.
Warnings (1)
Sequence 1
Warnings For external use only. Do not use Do not use on damaged or broken skin. When using this product When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
When Using (1)
Sequence 1
When using this product When using this product keep out of eyes. Rinse with water to remove.
OpenFDA raw payload
{'application_number': ['M020'],
'brand_name': ['SUN BUFF SPF 30 MINERAL SUNSCREEN'],
'generic_name': ['ZINC OXIDE/TITANIUM DIOXIDE'],
'is_original_packager': [True],
'manufacturer_name': ['SPF Ventures, LLC'],
'package_ndc': ['58274-030-01'],
'product_ndc': ['58274-030'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['TOPICAL'],
'spl_id': ['3f874062-ebac-8993-e063-6294a90abfc5'],
'spl_set_id': ['3f874062-ebab-8993-e063-6294a90abfc5'],
'substance_name': ['TITANIUM DIOXIDE', 'ZINC OXIDE'],
'unii': ['15FIX9V2JP', 'SOI2LOH54Z']}