Version
v1
Effective date
September 30, 2025
Original packager
Yes
Sections captured
12
Identifiers
- Document ID
- 40024b26-6118-7bae-e063-6294a90a33eb
- Set ID
- 40024b26-6117-7bae-e063-6294a90a33eb
- Application numbers
- M020
- Product NDCs
- 60771-0031
- Package NDCs
- 60771-0031-1
- Original packager NDCs
- —
Names & Manufacturers
- Brand names
- Pure velocity SUNSCREEN SPF 50
- Generic names
- ETHYLHEXYL METHOXYCINNAMATE,ZINC OXIDE
- Manufacturer names
- Guangzhou Haishi Biological Technology Co., Ltd.
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- ETHYLHEXYL METHOXYCINNAMATE, ZINC OXIDE
- Routes
- TOPICAL
- Pharmacologic class (PE)
- —
- Pharmacologic class (EPC)
- —
- Pharmacologic class (CS)
- —
- Mechanism of action
- —
Other identifiers
- NUI
- —
- RxCUI
- —
- UNII
- 4Y5P7MUD51, SOI2LOH54Z
- UPC
- —
Structured Label Sections
Active Ingredient (1)
Sequence 1
Active Ingredients ETHYLHEXYL METHOXYCINNAMATE ZINC OXIDE
Do Not Use (1)
Sequence 1
Do Not Use Do not use on damaged or broken skin.
Dosage And Administration (1)
Sequence 1
Dosage & administration Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.
Inactive Ingredient (1)
Sequence 1
Inactive ingredients WATER PETROLATUM ISOPROPYL PALMITATE CETEARYL GLUCOSIDE POLYDIMETHYLSILOXANE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER POLYISOBUTYLENE PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER SODIUM HYALURONATE TOCOPHERYL ACETATE POLYETHER-1 CITRIC ACID OLEANOL POLYETHER-3 PHOSPHATE PHENOXYETHANOL BUTANEDIOL IODOPROPYNYL BUTYLCARBAMATE TRIETHOXYOCTYLSILANE
Indications And Usage (1)
Sequence 1
Uses 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 Keep Out Of Reach Of Children
Package Label Principal Display Panel (1)
Purpose (1)
Sequence 1
Purpose SUNSCREEN
Spl Product Data Elements (1)
Sequence 1
Pure velocity SUNSCREEN SPF 50 ETHYLHEXYL METHOXYCINNAMATE,ZINC OXIDE PETROLATUM HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER ISOPROPYL PALMITATE POLYETHER-1 (2800 MPA.S) .ALPHA.-BUTYLDIMETHYLSILYL-AND .OMEGA.-3-METHACRYLOXYPROPYLDIMETHYLSILYL-TERMINATED POLYDIMETHYLSILOXANE (10000 MW) CITRIC ACID ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL METHOXYCINNAMATE ZINC OXIDE ZINC OXIDE WATER POLYISOBUTYLENE (1000 MW) SODIUM HYALURONATE 1,2-BUTANEDIOL IODOPROPYNYL BUTYLCARBAMATE CETEARYL GLUCOSIDE .ALPHA.-TOCOPHEROL ACETATE TRIETHOXYCAPRYLYLSILANE PHENOXYETHANOL
Stop Use (1)
Sequence 1
Stop Use Rinse with wate to remove. Stop use and ask doctor if rash occurs.
Warnings (1)
Sequence 1
Warnings For external use only
When Using (1)
Sequence 1
When Using When using this product keep out of eyes.
OpenFDA raw payload
{'application_number': ['M020'],
'brand_name': ['Pure velocity SUNSCREEN SPF 50'],
'generic_name': ['ETHYLHEXYL METHOXYCINNAMATE,ZINC OXIDE'],
'is_original_packager': [True],
'manufacturer_name': ['Guangzhou Haishi Biological Technology Co., Ltd.'],
'package_ndc': ['60771-0031-1'],
'product_ndc': ['60771-0031'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['TOPICAL'],
'spl_id': ['40024b26-6118-7bae-e063-6294a90a33eb'],
'spl_set_id': ['40024b26-6117-7bae-e063-6294a90a33eb'],
'substance_name': ['ETHYLHEXYL METHOXYCINNAMATE', 'ZINC OXIDE'],
'unii': ['4Y5P7MUD51', 'SOI2LOH54Z']}